title: A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)

summary: This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

study_start_date_type: Actual

ReferenceCitation: Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, Sears P, Gorbach S; OPT-80-004 Clinical Study Group. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis. 2012 Apr;12(4):281-9. doi: 10.1016/S1473-3099(11)70374-7. Epub 2012 Feb 8.

family: Cornely

full_name: Oliver A Cornely

given: Oliver A

family: Crook

full_name: Derrick W Crook

given: Derrick W

family: Esposito

full_name: Roberto Esposito

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family: Poirier

full_name: André Poirier

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family: Somero

full_name: Michael S Somero

given: Michael S

family: Weiss

full_name: Karl Weiss

given: Karl

family: Sears

full_name: Pamela Sears

given: Pamela

family: Gorbach

full_name: Sherwood Gorbach

given: Sherwood

journal_name: The Lancet Infectious Diseases

ReferenceCitation: D'Agostino RB Sr, Collins SH, Pencina KM, Kean Y, Gorbach S. Risk estimation for recurrent Clostridium difficile infection based on clinical factors. Clin Infect Dis. 2014 May;58(10):1386-93. doi: 10.1093/cid/ciu107. Epub 2014 Mar 5.

family: D'Agostino

full_name: Ralph B. D'Agostino

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family: Collins

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given: Sylva H.

family: Pencina

full_name: Karol M. Pencina

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family: Kean

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journal_name: Clinical Infectious Diseases

evidence: oa repository (via OAI-PMH title match)

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Risk Estimation for Recurrent Clostridium difficile Infection Based on Clinical Factors

ReferenceCitation: Cornely OA, Miller MA, Fantin B, Mullane K, Kean Y, Gorbach S. Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin. J Clin Oncol. 2013 Jul 1;31(19):2493-9. doi: 10.1200/JCO.2012.45.5899. Epub 2013 May 28.

name: Oliver A. Cornely, University Hospital of Cologne and Zentrum für Klinische Studien Köln–BMBF 01KN1106, Cologne, Germany; Mark A. Miller, Jewish General Hospital, Montreal, Quebec, Canada; Bruno Fantin, University Paris Diderot, Paris, France; Kathleen Mullane, University of Chicago, Chicago, IL; Yin Kean and Sherwood Gorbach, Optimer Pharmaceuticals, San Diego, CA; and Sherwood Gorbach, Tufts University, Boston, MA.

full_name: Oliver A. Cornely

title: Resolution of Clostridium difficile–Associated Diarrhea in Patients With Cancer Treated With Fidaxomicin or Vancomycin

ReferenceCitation: Cornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2:S154-61. doi: 10.1093/cid/cis462.

title: Treatment of First Recurrence of Clostridium difficile Infection: Fidaxomicin Versus Vancomycin

ReferenceCitation: Figueroa I, Johnson S, Sambol SP, Goldstein EJ, Citron DM, Gerding DN. Relapse versus reinfection: recurrent Clostridium difficile infection following treatment with fidaxomicin or vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2:S104-9. doi: 10.1093/cid/cis357.

title: Relapse Versus Reinfection: Recurrent Clostridium difficile Infection Following Treatment With Fidaxomicin or Vancomycin

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United States
Sweden
Germany
France
Belgium
Spain
Canada
United Kingdom


ReferenceType: derived

ReferenceCitation: Cortes J, Digumarti R, Parikh PM, Wetzler M, Lipton JH, Hochhaus A, Craig AR, Benichou AC, Nicolini FE, Kantarjian HM; Omacetaxine 203 Study Group. Phase 2 study of subcutaneous omacetaxine mepesuccinate for chronic-phase chronic myeloid leukemia patients resistant to or intolerant of tyrosine kinase inhibitors. Am J Hematol. 2013 May;88(5):350-4. doi: 10.1002/ajh.23408. Epub 2013 Mar 7.

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sequence: additional

name: Indian Cooperative Oncology Network; Mumbai; India

family: Parikh

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family: Wetzler

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name: Formerly of ChemGenex Pharmaceuticals; an indirect wholly owned subsidiary of Teva Pharmaceuticals; Petach Tikva; Israel

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genre_raw: journal-article

journal_name: American Journal of Hematology

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

enrollment_type: Actual

primary_purpose: Treatment

location_country:
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United States
India
France
Poland
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Germany
United Kingdom
Canada

location_facility:
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Teva Investigational Site 320
Teva Investigational Site 325
Teva Investigational Site 328
Teva Investigational Site 331
Teva Investigational Site 314
Teva Investigational Site 323
Teva Investigational Site 301
Teva Investigational Site 305
Teva Investigational Site 330
Teva Investigational Site 327
Teva Investigational Site 302
Teva Investigational Site 371
Teva Investigational Site 311
Teva Investigational Site 324
Teva Investigational Site 370
Teva Investigational Site 390
Teva Investigational Site 308
Teva Investigational Site 329
Teva Investigational Site 313
Teva Investigational Site 380
Teva Investigational Site 360
Teva Investigational Site 309
Teva Investigational Site 303
Teva Investigational Site 310
Teva Investigational Site 350
Teva Investigational Site 340
Teva Investigational Site 322

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate) in the Treatment of Patients With Chronic Myeloid Leukemia (CML) Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy

summary: A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceCitation: Lacroix A, Gu F, Schopohl J, Kandra A, Pedroncelli AM, Jin L, Pivonello R. Pasireotide treatment significantly reduces tumor volume in patients with Cushing's disease: results from a Phase 3 study. Pituitary. 2020 Jun;23(3):203-211. doi: 10.1007/s11102-019-01021-2.

family: Lacroix

full_name: André Lacroix

family: Gu

full_name: Feng Gu

given: Feng

family: Schopohl

full_name: Jochen Schopohl

given: Jochen

family: Kandra

full_name: Albert Kandra

given: Albert

family: Pedroncelli

full_name: Alberto M. Pedroncelli

given: Alberto M.

family: Jin

full_name: Lixian Jin

given: Lixian

family: Pivonello

full_name: Rosario Pivonello

given: Rosario

journal_name: Pituitary

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

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license_normalized: cc-by

version: publishedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Pasireotide treatment significantly reduces tumor volume in patients with Cushing’s disease: results from a Phase 3 study

ReferenceCitation: Yedinak CG, Hopkins S, Williams J, Ibrahim A, Cetas JS, Fleseriu M. Medical Therapy with Pasireotide in Recurrent Cushing's Disease: Experience of Patients Treated for At Least 1 Year at a Single Center. Front Endocrinol (Lausanne). 2017 Feb 27;8:35. doi: 10.3389/fendo.2017.00035. eCollection 2017.

family: Yedinak

full_name: Chris G. Yedinak

given: Chris G.

family: Hopkins

full_name: Sarah Hopkins

given: Sarah

family: Williams

full_name: Jessica Williams

given: Jessica

family: Ibrahim

full_name: Aly Ibrahim

given: Aly

family: Cetas

full_name: Justin Schultz Cetas

given: Justin Schultz

family: Fleseriu

full_name: Maria Fleseriu

given: Maria

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Frontiers in Endocrinology

oa_colors: green gold

evidence: oa journal (via doaj)

title: Medical Therapy with Pasireotide in Recurrent Cushing’s Disease: Experience of Patients Treated for At Least 1 Year at a Single Center

ReferenceCitation: Schopohl J, Gu F, Rubens R, Van Gaal L, Bertherat J, Ligueros-Saylan M, Trovato A, Hughes G, Salgado LR, Boscaro M, Pivonello R; Pasireotide B2305 Study Group. Pasireotide can induce sustained decreases in urinary cortisol and provide clinical benefit in patients with Cushing's disease: results from an open-ended, open-label extension trial. Pituitary. 2015 Oct;18(5):604-12. doi: 10.1007/s11102-014-0618-1.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inrap

title: Pasireotide can induce sustained decreases in urinary cortisol and provide clinical benefit in patients with Cushing’s disease: results from an open-ended, open-label extension trial

ReferenceCitation: MacKenzie Feder J, Bourdeau I, Vallette S, Beauregard H, Ste-Marie LG, Lacroix A. Pasireotide monotherapy in Cushing's disease: a single-centre experience with 5-year extension of phase III Trial. Pituitary. 2014 Dec;17(6):519-29. doi: 10.1007/s11102-013-0539-4.

title: Pasireotide monotherapy in Cushing’s disease: a single-centre experience with 5-year extension of phase III Trial

ReferenceCitation: Petersenn S, Newell-Price J, Findling JW, Gu F, Maldonado M, Sen K, Salgado LR, Colao A, Biller BM; Pasireotide B2305 Study Group. High variability in baseline urinary free cortisol values in patients with Cushing's disease. Clin Endocrinol (Oxf). 2014 Feb;80(2):261-9. doi: 10.1111/cen.12259. Epub 2013 Jul 15.

name: ENDOC Center for Endocrine Tumors Hamburg Germany

name: The Medical School University of Sheffield Sheffield UK

name: Division of Endocrinology, Metabolism, and Clinical Nutrition Medical College of Wisconsin Milwaukee WI USA

name: Department of Endocrinology Key Laboratory of Endocrinology Ministry of Health Peking Union Medical College Hospital Beijing China

name: Clinical Development, Oncology Business Unit Novartis Pharma AG Basel Switzerland

name: Oncology Biometrics and Data Management Novartis Pharmaceuticals Corporation Florham Park NJ USA

name: General Internal Medicine Service Hospital das Clínicas University of São Paulo Medical School São Paulo Brazil

name: Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia Università di Napoli ‘Federico II’ Naples Italy

name: Neuroendocrine Clinical Center Massachusetts General Hospital Boston MA USA

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Colao A, Petersenn S, Newell-Price J, Findling JW, Gu F, Maldonado M, Schoenherr U, Mills D, Salgado LR, Biller BM; Pasireotide B2305 Study Group. A 12-month phase 3 study of pasireotide in Cushing's disease. N Engl J Med. 2012 Mar 8;366(10):914-24. doi: 10.1056/NEJMoa1105743. Erratum in: N Engl J Med. 2012 Aug 23;367(8):780.

title: A 12-Month Phase 3 Study of Pasireotide in Cushing's Disease

location_country:
Italy
United States
Brazil
Mexico
Spain
Germany
Finland
France
Poland
Greece
Israel
Belgium
Argentina
China
Turkey
Denmark
Canada
Portugal

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8)

location_facility: Swedish Medical Center Dept.ofSeattle Neuroscience(2)

location_facility: Stanford University Medical Center Stanford Cancer Center (3)

location_facility: Columbia University Medical Center- New York Presbyterian Columbia University DeptofMed

location_facility: Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.

location_facility: Dana Farber Cancer Institute The Melanoma Program

location_facility: University Chicago Hospital Dept. of Univ of Chicago

location_facility: University of Texas Southwestern Medical Center Clinical-TranslationalRes.Ctr.

location_facility: Cleveland Clinic Foundation Dept. of Cleveland Clinic (6)

title: A Randomized, Double-blind Study to Assess the Safety and Efficacy of Different Dose Levels of Pasireotide (SOM230) Subcutaneous (sc) Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's Disease

summary: This study will evaluate the safety and efficacy of two different doses of Pasireotide in patients with de novo or recurrent/persistent Cushing's Disease.


ReferenceType: background

ReferenceCitation: Gattone VH 2nd, Wang X, Harris PC, Torres VE. Inhibition of renal cystic disease development and progression by a vasopressin V2 receptor antagonist. Nat Med. 2003 Oct;9(10):1323-6. Epub 2003 Sep 21.

ReferenceCitation: Torres VE, Wang X, Qian Q, Somlo S, Harris PC, Gattone VH 2nd. Effective treatment of an orthologous model of autosomal dominant polycystic kidney disease. Nat Med. 2004 Apr;10(4):363-4. Epub 2004 Feb 29.

ReferenceCitation: Torres VE, Meijer E, Bae KT, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang JJ, Czerwiec FS. Rationale and design of the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) 3-4 Study. Am J Kidney Dis. 2011 May;57(5):692-9. doi: 10.1053/j.ajkd.2010.11.029. Epub 2011 Feb 17.

ReferenceCitation: Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang J, Czerwiec FS; TEMPO 3:4 Trial Investigators. Tolvaptan in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2012 Dec 20;367(25):2407-18. doi: 10.1056/NEJMoa1205511. Epub 2012 Nov 3.

ReferenceCitation: Watkins PB, Lewis JH, Kaplowitz N, Alpers DH, Blais JD, Smotzer DM, Krasa H, Ouyang J, Torres VE, Czerwiec FS, Zimmer CA. Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database. Drug Saf. 2015 Nov;38(11):1103-13. doi: 10.1007/s40264-015-0327-3.

ReferenceCitation: Kher A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257-8. doi: 10.1056/NEJMc1300762.

ReferenceCitation: Spital A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257. doi: 10.1056/NEJMc1300762.

ReferenceCitation: Torres VE, Gansevoort RT, Czerwiec FS. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1259. doi: 10.1056/NEJMc1300762.

ReferenceCitation: Jouret F, Krzesinski JM. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258-9. doi: 10.1056/NEJMc1300762.

ReferenceCitation: Sexton DJ. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258. doi: 10.1056/NEJMc1300762.

ReferenceCitation: Nowak KL, Steele C, Gitomer B, Wang W, Ouyang J, Chonchol MB. Overweight and Obesity and Progression of ADPKD. Clin J Am Soc Nephrol. 2021 Jun;16(6):908-915. doi: 10.2215/CJN.16871020. Epub 2021 Jun 11.

family: Nowak

full_name: Kristen L. Nowak

given: Kristen L.

family: Steele

full_name: Cortney Steele

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family: Wang

full_name: Wenchyi Wang

given: Wenchyi

family: Ouyang

full_name: John Ouyang

given: John

family: Chonchol

full_name: Michel B. Chonchol

given: Michel B.

journal_name: Clinical Journal of the American Society of Nephrology

oa_host_type: publisher

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publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

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ReferenceCitation: Heida JE, Gansevoort RT, Torres VE, Devuyst O, Perrone RD, Lee J, Li H, Ouyang J, Chapman AB. The Effect of Tolvaptan on BP in Polycystic Kidney Disease: A Post Hoc Analysis of the TEMPO 3:4 Trial. J Am Soc Nephrol. 2021 Apr 22. pii: ASN.2020101512. doi: 10.1681/ASN.2020101512. [Epub ahead of print]

family: Heida

full_name: Judith E. Heida

given: Judith E.

family: Gansevoort

full_name: Ron T. Gansevoort

given: Ron T.

family: Torres

full_name: Vicente E. Torres

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family: Devuyst

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family: Perrone

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family: Li

full_name: Hui Li

given: Hui

family: Chapman

full_name: Arlene B. Chapman

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journal_name: Journal of the American Society of Nephrology

ReferenceCitation: Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.

family: Bennett

ReferenceCitation: McEwan P, Bennett Wilton H, Ong ACM, Ørskov B, Sandford R, Scolari F, Cabrera MV, Walz G, O'Reilly K, Robinson P. A model to predict disease progression in patients with autosomal dominant polycystic kidney disease (ADPKD): the ADPKD Outcomes Model. BMC Nephrol. 2018 Feb 13;19(1):37. doi: 10.1186/s12882-017-0804-2.

evidence: oa repository (via OAI-PMH title and first author match)

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repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

ReferenceCitation: Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Dandurand A, Ouyang J, Czerwiec FS, Blais JD; TEMPO 4:4 Trial Investigators. Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: the TEMPO 4:4 Trial. Nephrol Dial Transplant. 2018 Mar 1;33(3):477-489. doi: 10.1093/ndt/gfx043.

name: Division of Nephrology and Hypertension, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA

name: Division of Nephrology, Section of Nephrology, University of Chicago, Chicago, IL, USA

name: Division of Nephrology, Cliniques Universitaires St Luc, Université catholique de Louvain Medical School, Brussels, Belgium

name: Institute of Physiology, Zurich Center for Integrative Human Physiology (ZIHP), University of Zurich, Zurich, Switzerland

name: Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

name: Department of Medicine, Division of Nephrology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA

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ReferenceCitation: Muto S, Kawano H, Higashihara E, Narita I, Ubara Y, Matsuzaki T, Ouyang J, Torres VE, Horie S. The effect of tolvaptan on autosomal dominant polycystic kidney disease patients: a subgroup analysis of the Japanese patient subset from TEMPO 3:4 trial. Clin Exp Nephrol. 2015 Oct;19(5):867-77. doi: 10.1007/s10157-015-1086-2. Epub 2015 Feb 7.

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United States
Netherlands
Germany
France
Japan
Poland
Romania
Belgium
Argentina
Australia
Russian Federation
Denmark
Canada
United Kingdom

location_facility: Klinika Chorób Wewnętrznych i Nefrologii

location_facility: Spitalul Clinic de Nefrologie Dr. Carol Davila

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location_facility: National Hospital Organization Kyoto Medical Center

location_facility: Royal Free and University College Medical School

location_facility: Międzyleski Szpital Specjalistyczny w Warszawie

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG

location_facility: Akademicki Szpital Kliniczny im J Mikulicza Radeckiego

location_facility: Kemerovo Medical Academy, Regional Clinical Hospital

location_facility: Sussex Renal Unit Royal Sussex County Hospital

location_facility: Queen Elizabeth II Health Science Center, Division of Nephrology

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: University of Virginia, Nephrology Clinical Research Center

location_facility: Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie

location_facility: Coastal Nephrology Associates Research Center, LLC

location_facility: University of Colorado Health Sciences Center

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Szpital Praski, Samodzielny Publiczny ZOZ

location_facility: University of Pennsylvania Medical Center

location_facility: Università Vita e Salute, Ospedale San Raffaele

location_facility: Niigata University Medical & Dental Hospital

location_facility: University of North Carolina, UNC, Kidney Center

location_facility: Saitama Medical Center Jichi Medical University

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Hospital Privado-Centro Medico de Cordoba

location_facility: Jacksonville Center for Clinical Research

location_facility: Klinik für Nieren- und Hochdruckkrankheiten

location_facility: Tokyo Medical & Dental University Hospital, Faculty of Medicine

location_facility: Tokyo Women's Medical University Hospital

title: A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease

summary: This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.


ReferenceCitation: Foss F, Pro B, Miles Prince H, Sokol L, Caballero D, Horwitz S, Coiffier B. Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T-cell lymphoma. Cancer Med. 2017 Jan;6(1):36-44. doi: 10.1002/cam4.939. Epub 2016 Dec 16.

ReferenceCitation: Shustov A, Coiffier B, Horwitz S, Sokol L, Pro B, Wolfson J, Balser B, Eisch R, Popplewell L, Prince HM, Allen SL, Piekarz R, Bates S. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma. 2017 Oct;58(10):2335-2341. doi: 10.1080/10428194.2017.1295143. Epub 2017 Mar 7.

ReferenceType: result

ReferenceCitation: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. doi: 10.1200/JCO.2011.37.4223. Epub 2012 Jan 23.

name: Author affiliations appear at the end of this article.

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given: Bertrand

family: Pro

full_name: Barbara Pro

given: Barbara

family: Prince

full_name: H. Miles Prince

given: H. Miles

family: Foss

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given: Francine

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full_name: Dolores Caballero

given: Dolores

family: Borchmann

full_name: Peter Borchmann

given: Peter

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Wilhelm

full_name: Martin Wilhelm

given: Martin

family: Pinter-Brown

full_name: Lauren Pinter-Brown

given: Lauren

family: Padmanabhan

full_name: Swaminathan Padmanabhan

given: Swaminathan

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full_name: Jean Nichols

given: Jean

family: Carroll

full_name: Susan Carroll

given: Susan

family: Balser

full_name: John Balser

full_name: Barbara Balser

family: Horwitz

full_name: Steven Horwitz

given: Steven

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy

ReferenceCitation: Horwitz S, Coiffier B, Foss F, Prince HM, Sokol L, Greenwood M, Caballero D, Morschhauser F, Pinter-Brown L, Iyer SP, Shustov A, Nichols J, Balser J, Balser B, Pro B. Utility of ¹⁸fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Apr;26(4):774-779. doi: 10.1093/annonc/mdv010. Epub 2015 Jan 20.

full_name: S. Horwitz

given: S.

full_name: B. Coiffier

given: B.

full_name: F. Foss

given: F.

full_name: H.M. Prince

full_name: L. Sokol

given: L.

repository_institution: University of Melbourne - Minerva Access

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - SHS

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

title: Utility of18fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma

ReferenceCitation: Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016 Mar 10;9:22. doi: 10.1186/s13045-016-0243-8. Erratum in: J Hematol Oncol. 2017 Sep 18;10 (1):154.

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

ReferenceCitation: Foss F, Coiffier B, Horwitz S, Pro B, Prince HM, Sokol L, Greenwood M, Lerner A, Caballero D, Baran E, Kim E, Nichols J, Balser B, Wolfson J, Whittaker S. Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma. Biomark Res. 2014 Sep 8;2:16. doi: 10.1186/2050-7771-2-16. eCollection 2014.

ReferenceCitation: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7:11. doi: 10.1186/1756-8722-7-11.

location_country:
United States
Sweden
France
Czechia
Poland
Australia
Spain
Germany
United Kingdom
Ukraine

location_facility: Accelerated Community Oncology Research Network Inc ACORN

location_facility: University Hospital of Kralovske Vinohrady

location_facility: Taussig Cancer Center Cleveland Clinic Foundation

location_facility: Charite Universitatsmedizin Berlin campus Virchow Klinikum Centrum fur Tumormedizin

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: UT Southwestern Medical Center Simmons Comprehensive Cancer Center

location_facility: Mater Private Medical Centre - Haematology and Oncology Clinics of Australasia Research Centre

location_facility: Hematology Oncology Assoc. of IL Orchard Research LLC

location_facility: Consultants in Blood Disorders and Cancer

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Cancer Care and Hematology Specialists of Chicagoland

location_facility: Winship Cancer Institute of Emory University

location_facility: National Cancer Institute Department Of Conservative Methods Of Treatment

location_facility: Klinikum der Universitat Munchen-Grosshadern

location_facility: Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine

location_facility: R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology

location_facility: Klinika Hematologii Akademickie Centrum Kliniczne Akademii Medycznej w Gdansku

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: Catherine Lewis Centre - Hematology Department

title: A Phase II, Multicenter, Open-Label Trial Evaluating The Activity And Tolerability Of Romidepsin (Depsipeptide, FK228) In Progressive Or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy (GPI-06-0002)

summary: The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.


ReferenceCitation: Gyssens IC, Dryden M, Kujath P, Nathwani D, Schaper N, Hampel B, Reimnitz P, Alder J, Arvis P. A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections. J Antimicrob Chemother. 2011 Nov;66(11):2632-42. doi: 10.1093/jac/dkr344. Epub 2011 Sep 6.

family: Gyssens

full_name: Inge C. Gyssens

given: Inge C.

family: Dryden

full_name: Matthew Dryden

family: Kujath

full_name: Peter Kujath

family: Nathwani

full_name: Dilip Nathwani

given: Dilip

family: Schaper

full_name: Nicolaas Schaper

given: Nicolaas

family: Hampel

full_name: Barbara Hampel

given: Barbara

family: Reimnitz

full_name: Peter Reimnitz

family: Alder

full_name: Jeff Alder

given: Jeff

family: Arvis

full_name: Pierre Arvis

given: Pierre

journal_name: Journal of Antimicrobial Chemotherapy

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

ReferenceCitation: Schaper NC, Dryden M, Kujath P, Nathwani D, Arvis P, Reimnitz P, Alder J, Gyssens IC. Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study. Infection. 2013 Feb;41(1):175-86. doi: 10.1007/s15010-012-0367-x. Epub 2012 Nov 23.

full_name: N. C. Schaper

given: N. C.

full_name: M. Dryden

given: M.

full_name: P. Kujath

given: P.

full_name: D. Nathwani

given: D.

full_name: P. Arvis

full_name: P. Reimnitz

full_name: J. Alder

given: J.

full_name: I. C. Gyssens

ReferenceCitation: D'Onofrio V, Monnier AA, Kremer C, Stappers MHT, Netea MG, Gyssens IC. Lesion size is associated with genetic polymorphisms in TLR1, TLR6, and TIRAP genes in patients with major abscesses and diabetic foot infections. Eur J Clin Microbiol Infect Dis. 2020 Feb;39(2):353-360. doi: 10.1007/s10096-019-03732-7. Epub 2019 Nov 30.

journal_name: European Journal of Clinical Microbiology & Infectious Diseases

location_country:
Italy
Austria
South Africa
United Kingdom
Netherlands
Spain
France
Bulgaria
Greece
Israel
Lithuania
Poland
Hungary
Belgium
Ireland
Romania
Russian Federation
Germany
Latvia
Ukraine

title: A Prospective, Randomized, Double Dummy, Double Blind, Multinational, Multicenter Trial Comparing the Safety and Efficacy of Sequential (Intravenous/Oral) Moxifloxacin 400 mg OD to Intravenous Piperacillin/Tazobactam 4.0/0.5 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanic Acid Tablets 875/125 mg Every 12 Hours for the Treatment of Subjects With Complicated Skin and Skin Structure Infections

summary: Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be photographed. The patients will be randomly assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e., one of the reference treatments for this kind of infection). The maximum treatment duration will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients will have a physical examination every day. On Day 3-5 during therapy as well as at the end of treatment, the patients will have repeated examinations. These tests and evaluations will be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine samples will be taken only if judged necessary by the physicians.


title: A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma

summary: To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.

design_allocation: Randomized

lead_sponsor: Vical

location_country:
Italy
Brazil
United States
Switzerland
Netherlands
Germany
France
Poland
Israel
Belgium
Russian Federation
Spain
Turkey
Canada

location_facility:
Location #115
Location #90
Location #28
Location #111
Location #95
Location #101
Location #52
Location #27
Location #45
Location #1
Location #59
Location #72
Location #19
Location #74
Location #61
Location #11
Location #26
Location #48
Location #103
Location #7
Location #113
Location #36
Location #121
Location #82
Location # 75
Location #123
Location #106
Location #44
Location #104
Location #87
Location #67
Location #35
Location #89
Location #46
Location #32
Location #117
Location #62
Location #85
Location #78
Location #105
Location #57
Location #41
Location #34
Location #81
Location #97
Location #109
Location #20
Location #37
Location #84
Location #38
Location #60
Location #12
Location #114
Location #93
Location #99
Location #91
Location #118
Location #65
Location #86
Location #122
Location #68
Location #9
Location #16
Location #8
Location #43
Location #100
Location #102
Location #33
Location #116
Location #112
Location #79
Location #66
Location #51
Location #63
Location #80
Location #94
Location #58
Location #40
Location #24
Location #54
Location #110
Location #47
Location #50
Location #88
Location #124
Location #4
Location #55
Location #23


title: A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients

summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.

lead_sponsor: Pfizer

location_country:
Finland
Romania
Australia
Belgium
Russian Federation
Czech Republic
Ukraine
France
Panama
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
Sweden
Netherlands
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Spain
Turkey


title: A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.

summary: This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

ReferenceCitation: Gianni L, Romieu GH, Lichinitser M, Serrano SV, Mansutti M, Pivot X, Mariani P, Andre F, Chan A, Lipatov O, Chan S, Wardley A, Greil R, Moore N, Prot S, Pallaud C, Semiglazov V. AVEREL: a randomized phase III Trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer. J Clin Oncol. 2013 May 10;31(14):1719-25. doi: 10.1200/JCO.2012.44.7912. Epub 2013 Apr 8.

name: Luca Gianni, Ospedale San Raffaele; Paola Mariani, Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale Tumori, Milan; Mauro Mansutti, University Hospital of Udine, Udine, Italy; Gilles H. Romieu, Centre Régionale de Lutte contre le Cancer, Val d'Aurelle, Montpellier; Xavier Pivot, University Hospital Jean Minjoz, Besançon; Fabrice Andre, Gustave Roussy Institute, Villejuif, France; Michail Lichinitser, N.N. Blokhin Russian Oncology Research Center, Moscow; Oleg Lipatov,...

family: Gianni

full_name: Luca Gianni

given: Luca

family: Romieu

full_name: Gilles H. Romieu

given: Gilles H.

family: Lichinitser

full_name: Michail Lichinitser

given: Michail

family: Serrano

full_name: Sergio V. Serrano

given: Sergio V.

family: Mansutti

full_name: Mauro Mansutti

given: Mauro

family: Pivot

full_name: Xavier Pivot

given: Xavier

family: Mariani

full_name: Paola Mariani

given: Paola

family: Andre

full_name: Fabrice Andre

given: Fabrice

family: Chan

full_name: Arlene Chan

given: Arlene

family: Lipatov

full_name: Oleg Lipatov

given: Oleg

full_name: Stephen Chan

given: Stephen

family: Wardley

full_name: Andrew Wardley

given: Andrew

family: Greil

full_name: Richard Greil

given: Richard

family: Moore

full_name: Nicola Moore

given: Nicola

family: Prot

full_name: Sylvie Prot

given: Sylvie

family: Pallaud

full_name: Celine Pallaud

given: Celine

family: Semiglazov

full_name: Vladimir Semiglazov

given: Vladimir

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: AVEREL: A Randomized Phase III Trial Evaluating Bevacizumab in Combination With Docetaxel and Trastuzumab As First-Line Therapy for HER2-Positive Locally Recurrent/Metastatic Breast Cancer

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
Bosnia and Herzegovina
Brazil
United Kingdom
Mexico
Uruguay
France
Romania
Argentina
Australia
Russian Federation
Spain
Turkey
Canada
Czech Republic


ReferenceCitation: Lim JK, Chang AY, Zaman A, Martin P, Fernandez-Rodriguez CM, Korkmaz M, Rossi S, Ford JM, Noonan T, Cooney E, Navarro V, Colombato L. Clinical Outcome Event Adjudication in a 10-Year Prospective Study of Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B. J Clin Transl Hepatol. 2020 Dec 28;8(4):377-384. doi: 10.14218/JCTH.2020.00039. Epub 2020 Oct 10.

family: Lim

full_name: Joseph K Lim

given: Joseph K

family: Chang

full_name: Alex Y Chang

given: Alex Y

family: Zaman

full_name: Atif Zaman

given: Atif

family: Martin

full_name: Paul Martin

given: Paul

family: Fernandez-Rodriguez

full_name: Conrado M Fernandez-Rodriguez

given: Conrado M

family: Korkmaz

full_name: Mete Korkmaz

given: Mete

family: Rossi

full_name: Simona Rossi

given: Simona

family: Ford

full_name: James M Ford

given: James M

family: Noonan

full_name: Tamara Noonan

given: Tamara

family: Cooney

full_name: Elizabeth Cooney

given: Elizabeth

family: Navarro

full_name: Victor Navarro

given: Victor

family: Colombato

full_name: Luis Colombato

given: Luis

journal_name: Journal of Clinical and Translational Hepatology

oa_colors: green other

evidence: open (via page says license)

publisher: Xia & He Publishing

publisher_dissemination: Xia & He Publishing

publisher_group: Xia & He Publishing

publisher_normalized: Xia & He Publishing

ReferenceCitation: Hou JL, Zhao W, Lee C, Hann HW, Peng CY, Tanwandee T, Morozov V, Klinker H, Sollano JD, Streinu-Cercel A, Cheinquer H, Xie Q, Wang YM, Wei L, Jia JD, Gong G, Han KH, Cao W, Cheng M, Tang X, Tan D, Ren H, Duan Z, Tang H, Gao Z, Chen S, Lin S, Sheng J, Chen C, Shang J, Han T, Ji Y, Niu J, Sun J, Chen Y, Cooney EL, Lim SG. Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries. Clin Gastroenterol Hepatol. 2020 Feb;18(2):457-467.e21. doi: 10.1016/j.cgh.2019.07.010. Epub 2019 Jul 12.

family: Hou

full_name: Jin-Lin Hou

given: Jin-Lin

family: Zhao

full_name: Wei Zhao

given: Wei

family: Lee

full_name: Changhyeong Lee

given: Changhyeong

family: Hann

full_name: Hie-Won Hann

given: Hie-Won

family: Peng

full_name: Cheng-Yuan Peng

given: Cheng-Yuan

family: Tanwandee

full_name: Tawesak Tanwandee

given: Tawesak

family: Morozov

full_name: Viacheslav Morozov

given: Viacheslav

family: Klinker

full_name: Hartwig Klinker

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Hou JL, Jia JD, Wei L, Zhao W, Wang YM, Cheng M, Tang X, Tan DM, Ren H, Tang H, Cohen D, Llamoso C. Efficacy and safety of entecavir treatment in a heterogeneous CHB population from a 'real-world' clinical practice setting in China. J Viral Hepat. 2013 Nov;20(11):811-20.

location_country:
Greece
Romania
Russian Federation
Taiwan
India
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
Philippines
Singapore
Portugal
China
United States
Germany
Italy
Brazil
Mexico
Czechia
Spain
Turkey

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: University Of Miami Center For Liver Diseases

location_facility: Tulane University Health Sciences Center

title: Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study

summary: The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.


type: Other Identifier

title: Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

summary: To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

ReferenceCitation: Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12:55. doi: 10.1186/1465-9921-12-55.

family: Jones

full_name: Paul W Jones

given: Paul W

family: Rennard

full_name: Stephen I Rennard

given: Stephen I

family: Agusti

full_name: Alvar Agusti

given: Alvar

family: Chanez

full_name: Pascal Chanez

given: Pascal

family: Magnussen

full_name: Helgo Magnussen

given: Helgo

family: Fabbri

full_name: Leonardo Fabbri

given: Leonardo

family: Donohue

full_name: James F Donohue

given: James F

family: Bateman

full_name: Eric D Bateman

given: Eric D

family: Gross

full_name: Nicholas J Gross

given: Nicholas J

family: Lamarca

full_name: Rosa Lamarca

given: Rosa

family: Caracta

full_name: Cynthia Caracta

given: Cynthia

family: Gil

full_name: Esther Garcia Gil

given: Esther Garcia

currency_apc_doaj: GBP

journal_name: Respiratory Research

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repository_institution: University of Cape Town - Open University of Cape Town

repository_normalized: localhost

repository_institution: St George's University of London - St George's Online Research Archive

location_country:
Italy
Austria
United Kingdom
Netherlands
Andorra
Bulgaria
France
Poland
Romania
Hungary
Belgium
Russian Federation
Spain
Denmark
Germany
Czech Republic

location_facility:
Almirall Investigational Sites#682
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Almirall Investigational Sites#777


title: Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

acronym: CLARINET

summary: The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

ReferenceCitation: Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.

family: Caplin

full_name: Martyn E. Caplin

given: Martyn E.

family: Pavel

full_name: Marianne Pavel

given: Marianne

family: Ćwikła

full_name: Jarosław B. Ćwikła

given: Jarosław B.

family: Phan

full_name: Alexandria T. Phan

given: Alexandria T.

family: Raderer

full_name: Markus Raderer

given: Markus

family: Sedláčková

full_name: Eva Sedláčková

given: Eva

family: Cadiot

full_name: Guillaume Cadiot

given: Guillaume

family: Wolin

full_name: Edward M. Wolin

given: Edward M.

family: Capdevila

full_name: Jaume Capdevila

given: Jaume

family: Wall

full_name: Lucy Wall

given: Lucy

family: Rindi

full_name: Guido Rindi

given: Guido

family: Langley

full_name: Alison Langley

given: Alison

family: Martinez

full_name: Séverine Martinez

given: Séverine

family: Blumberg

full_name: Joëlle Blumberg

given: Joëlle

family: Ruszniewski

full_name: Philippe Ruszniewski

given: Philippe

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Lanreotide in Metastatic Enteropancreatic Neuroendocrine Tumors

ReferenceCitation: Caplin ME, Pavel M, Phan AT, Ćwikła JB, Sedláčková E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14.

family: Thanh

repository_institution: University College London - UCL Discovery

ReferenceCitation: Lybaert W, Van Hul E, Woestenborghs H. Long-term disease control of a pancreatic neuroendocrine tumor with lanreotide autogel(®): a case report. Case Rep Oncol. 2014 Sep 26;7(3):673-80. doi: 10.1159/000368207. eCollection 2014 Sep.

title: Long-Term Disease Control of a Pancreatic Neuroendocrine Tumor with Lanreotide Autogel®: A Case Report

location_country:
Italy
Austria
Sweden
India
United Kingdom
Netherlands
Germany
France
Poland
Slovakia
Belgium
Spain
Denmark
United States
Czech Republic

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a

location_facility: Basingstoke and North Hampshire Hospital

location_facility: Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu

location_facility: Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie

location_facility: Vychodoslovensky onkologicky ustav, Rastislavova

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul.

location_facility: Hospital Nuestra Senora de la Candelaria

location_facility: Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego


title: Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.

summary: This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.

ReferenceCitation: Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.

family: Sullivan

full_name: Sean D Sullivan

given: Sean D

family: Alfonso-Cristancho

full_name: Rafael Alfonso-Cristancho

given: Rafael

family: Conner

full_name: Chris Conner

given: Chris

family: Hammer

full_name: Mette Hammer

given: Mette

family: Blonde

full_name: Lawrence Blonde

given: Lawrence

journal_name: Cardiovascular Diabetology

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998. Review.

family: McGill

full_name: Janet B. McGill

given: Janet B.

journal_name: Postgraduate Medicine

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Insights from the Liraglutide Clinical Development Program—the Liraglutide Effect and Action in Diabetes (LEAD) Studies

ReferenceCitation: Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simó R; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2046-55. doi: 10.1007/s00125-009-1472-y. Epub 2009 Aug 14.

family: Russell-Jones

full_name: D. Russell-Jones

given: D.

name: on behalf of the Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group

family: Vaag

full_name: A. Vaag

given: A.

family: Schmitz

full_name: O. Schmitz

given: O.

family: Sethi

full_name: B. K. Sethi

given: B. K.

family: Lalic

full_name: N. Lalic

given: N.

family: Antic

full_name: S. Antic

given: S.

family: Zdravkovic

full_name: M. Zdravkovic

given: M.

ReferenceCitation: Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x. Review.

ReferenceCitation: Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.

journal_name: The Journal of Clinical Endocrinology & Metabolism

title: Liraglutide Treatment Is Associated with a Low Frequency and Magnitude of Antibody Formation with No Apparent Impact on Glycemic Response or Increased Frequency of Adverse Events: Results from the Liraglutide Effect and Action in Diabetes (LEAD) Trials

ReferenceCitation: Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes ≥65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.

journal_name: The American Journal of Geriatric Pharmacotherapy

title: Comparison of the Efficacy and Tolerability Profile of Liraglutide, a Once-Daily Human GLP-1 Analog, in Patients With Type 2 Diabetes ≥65 and <65 Years of Age: A Pooled Analysis from Phase III Studies

ReferenceCitation: Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13.

ReferenceCitation: Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

ReferenceCitation: Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

name: Division of Diabetes, Endocrinology and Metabolism, Department of Medicine; Vanderbilt University School of Medicine; Nashville; TN; USA

name: Division of Endocrinology Diabetes and Nutrition, St Luke's-Roosevelt Hospital, Columbia University; New York; NY; USA

name: Diabetes Care Center; University of North Carolina School of Medicine; Chapel Hill; NC; USA

name: Novo Nordisk Pharma Ltd; Crawley; West Sussex; UK

name: Department of Diabetes and Endocrinology, Royal Surrey County Hospital, University of Surrey; Guildford; Surrey; UK

name: Samuel Lunenfeld Research Institute; Mount Sinai Hospital, University of Toronto; Toronto; ON; Canada

ReferenceCitation: Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

title: A meta-analysis of serious adverse events reported with exenatide and liraglutide: Acute pancreatitis and cancer

ReferenceCitation: King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

title: Liraglutide Achieves A1C Targets More often than Sitagliptin or Exenatide when Added to Metformin in Patients with Type 2 Diabetes and a Baseline A1C <8.0%

ReferenceCitation: Buse JB, Peters A, Russell-Jones D, Furber S, Donsmark M, Han J, MacConell L, Maggs D, Diamant M. Is insulin the most effective injectable antihyperglycaemic therapy? Diabetes Obes Metab. 2015 Feb;17(2):145-51. doi: 10.1111/dom.12402. Epub 2014 Nov 9.

name: University of North Carolina School of Medicine Medicine/Endocrinology  Chapel Hill NC USA

name: Keck School of Medicine University of Southern California  Los Angeles CA USA

name: Endocrinology and Metabolism, Royal Surrey County Hospital  Guildford UK

name: Novo Nordisk Pharmaceuticals  Sydney Australia

name: Amylin Pharmaceuticals LLC  San Diego CA USA

name: VU University Medical Center Diabetes Center, Department of Internal Medicine  Amsterdam The Netherlands

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

title: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials

ReferenceCitation: Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.

journal_name: Journal of Diabetes and its Complications

title: Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: Insights from a patient-level pooled analysis of six randomized clinical trials

location_country:
Italy
Austria
Brazil
South Africa
Former Serbia and Montenegro
India
Netherlands
Philippines
Finland
France
Poland
Slovakia
Norway
Argentina
Russian Federation
Spain
Denmark
United Kingdom


title: A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg Oral Dosing With the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

summary: This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.

primary_purpose: Prevention

ReferenceCitation: Altorjay A, Melson T, Chinachoit T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV Jr. Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. Arch Surg. 2011 Feb;146(2):201-6. doi: 10.1001/archsurg.2010.327.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
United States
Hong Kong
Philippines
Pakistan
France
Thailand
Hungary
Ireland
Germany
United Kingdom
Canada


title: An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER)

acronym: SILVER

summary:
The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD).

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

enrollment_type: Anticipated

ReferenceCitation: Montgomery SA, Locklear JC, Svedsäter H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.

family: Montgomery

full_name: Stuart A. Montgomery

given: Stuart A.

family: Locklear

full_name: Julie C. Locklear

given: Julie C.

family: Svedsäter

full_name: Henrik Svedsäter

given: Henrik

family: Eriksson

full_name: Hans Eriksson

given: Hans

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6.

name: Department of Psychiatry; University of Cape Town; Cape Town; South Africa

family: Stein

full_name: Dan J. Stein

given: Dan J.

name: Department of Psychiatry and Psychotherapy; University of Goettingen; Goettingen; Germany

family: Bandelow

full_name: Borwin Bandelow

given: Borwin

name: Affiliated Research Institute Inc.; San Diego; California; USA

family: Merideth

full_name: Charles Merideth

given: Charles

family: Olausson

full_name: Bengt Olausson

given: Bengt

family: Szamosi

full_name: Johan Szamosi

given: Johan

journal_name: Human Psychopharmacology: Clinical and Experimental

ReferenceCitation: Bandelow B, Chouinard G, Bobes J, Ahokas A, Eggens I, Liu S, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20. doi: 10.1017/S1461145709990423. Epub 2009 Aug 20.

family: Chouinard

full_name: Guy Chouinard

given: Guy

family: Bobes

full_name: Julio Bobes

given: Julio

family: Ahokas

full_name: Antti Ahokas

given: Antti

family: Eggens

full_name: Ivan Eggens

given: Ivan

family: Liu

full_name: Sherry Liu

given: Sherry

journal_name: The International Journal of Neuropsychopharmacology

repository_institution: Ministerio de Educación, Cultura y Deporte - Consultation of the Doctoral Thesis Database (TESEO)

location_country:
South Africa
Sweden
Mexico
Germany
Finland
France
Bulgaria
Slovakia
Norway
Romania
Argentina
Spain
Denmark
Canada
Czech Republic


title: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohn's Patients With Fistulas

summary: The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).

ReferenceCitation: Hay JW, Hay AR. Inflammatory bowel disease: costs-of-illness. J Clin Gastroenterol. 1992 Jun;14(4):309-17.

ReferenceCitation: Hugot JP, Chamaillard M, Zouali H, Lesage S, Cézard JP, Belaiche J, Almer S, Tysk C, O'Morain CA, Gassull M, Binder V, Finkel Y, Cortot A, Modigliani R, Laurent-Puig P, Gower-Rousseau C, Macry J, Colombel JF, Sahbatou M, Thomas G. Association of NOD2 leucine-rich repeat variants with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):599-603.

ReferenceCitation: Ogura Y, Bonen DK, Inohara N, Nicolae DL, Chen FF, Ramos R, Britton H, Moran T, Karaliuskas R, Duerr RH, Achkar JP, Brant SR, Bayless TM, Kirschner BS, Hanauer SB, Nuñez G, Cho JH. A frameshift mutation in NOD2 associated with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):603-6.

ReferenceCitation: Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology. 1979 Oct;77(4 Pt 2):843-6.

ReferenceCitation: Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80.

ReferenceCitation: Hellers G, Bergstrand O, Ewerth S, Holmström B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7.

ReferenceCitation: Farmer RG, Hawk WA, Turnbull RB Jr. Clinical patterns in Crohn's disease: a statistical study of 615 cases. Gastroenterology. 1975 Apr;68(4 Pt 1):627-35.

ReferenceCitation: Gray BK, Lockhartmummery HE, Morson BC. Crohn's disease of the anal region. Gut. 1965 Dec;6(6):515-24.

ReferenceCitation: Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. Review.

ReferenceCitation: Schwartz DA, Herdman CR. Review article: The medical treatment of Crohn's perianal fistulas. Aliment Pharmacol Ther. 2004 May 1;19(9):953-67. Review.

ReferenceCitation: Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405.

ReferenceCitation: Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7.

ReferenceCitation: Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9.

ReferenceCitation: Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85.

lead_sponsor: Ocera Therapeutics

location_country:
Austria
United States
United Kingdom
Netherlands
Germany
France
Poland
Israel
Hungary
Belgium
Canada
Czech Republic

location_facility: University Hospital Gasthuisberg, University of Leuven

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Regional Hospital Liberec, Department of Gastroenterology

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet

location_facility: CHU Hopital Nord, Service de Gastro-enterologie et nutrition

location_facility: Korektalnej Uniwersytetu Medycznego w Lodzi

location_facility: Hopital Nord, Service de Gastro-Enterologie

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 im. Heliodora

location_facility: Bristol Royal Infirmary, Dept. of Gastroenterology

location_facility: Mount Sinai School of Medicine, IBD Research Center

location_facility: Katedra Klinika Gastroenterologi, Akedemil Medycanej we Wroclawiu

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej AM

location_facility: University Hospital Olomouc, 2nd Internal Department

location_facility: Thomayer's University Hospital Prague, 2nd Internal Department

location_facility: Indiana University, Outpatient Clinical Research Facility

location_facility: Drs. Scherf, Chessler, Zingler & Spinnell, MD, PA

location_facility: Szegedi Tudomanyegyetem, I.sz. Belgyogyaszati Klinika

location_facility: Universitatsklinik Heidelberg Abteilung Gastroenterologie und Hepatologie

location_facility: CHU Hotel Dieu, Institut des Maladies de l'Appareil Digestif

location_facility: Hopital Claude Huriez, Service des maladies de l'appareil disgestif

location_facility: Long Island Clinical Research Associates, LLP

location_facility: Erasmus MC, Department of Gastroenterology and Hepatology

location_facility: Miskolc Megyei Jogu Onkormanyzat Semmelweis Oktato Korhaz-Rendelointezet

location_facility: Universitatsklinik fur Innere Medizin I der PMU

location_facility: Leicester General Hospital - GI Research Unit

location_facility: John Radcliffe Hospital, Dept. of Gastroenterology

location_facility: University College London Hospital, Dept. of Gastroenterology

location_facility: Zakaznych Szpitala Uniwersyteckiego w Krakowie

location_facility: Rabin Medical Center, Bellinson Hospital

location_facility: University of Louisville, Department of Surgery

location_facility: Klinikum der Johann-Wolfgang-Goethe Universitat Frankfurt am Main

location_facility: Univ Klinik fur Innere Medizin Innsbruck

location_facility: Institute for Clinical and Experimental Medicine

location_facility: University Hospital Brno, Internal and Gastroenterology Department

location_facility: University of Kentucky Chandler Medical Center

location_facility: Cleveland Clinic - Department of Gastroenterology

location_facility: Universitat Rostock - Midizinische Fakultat

location_facility: University Hospital Prague 2, 4th Department of Internal Medicine

location_facility: Hopital Saint-Eloi, Service de Gastro-enterologie et transplantation

location_facility: The Penn State University, Milton S. Hershey Medical Center

location_facility: Metropolitan Gastroenterology Group/Chevy Chase Clinical Research


title: Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.

summary: This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

ReferenceCitation: Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.

family: Sullivan

full_name: Sean D Sullivan

given: Sean D

family: Alfonso-Cristancho

full_name: Rafael Alfonso-Cristancho

given: Rafael

family: Conner

full_name: Chris Conner

given: Chris

family: Hammer

full_name: Mette Hammer

given: Mette

family: Blonde

full_name: Lawrence Blonde

given: Lawrence

ReferenceCitation: Marre M, Shaw J, Brändle M, Bebakar WM, Kamaruddin NA, Strand J, Zdravkovic M, Le Thi TD, Colagiuri S; LEAD-1 SU study group. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabet Med. 2009 Mar;26(3):268-78. doi: 10.1111/j.1464-5491.2009.02666.x.

family: Marre

full_name: M. Marre

family: Shaw

full_name: J. Shaw

given: J.

family: Brändle

full_name: M. Brändle

family: Bebakar

full_name: W. M. W. Bebakar

given: W. M. W.

family: Kamaruddin

full_name: N. A. Kamaruddin

given: N. A.

family: Strand

full_name: J. Strand

family: Le Thi

full_name: T. D. Le Thi

given: T. D.

family: Colagiuri

full_name: S. Colagiuri

journal_name: Diabetic Medicine

ReferenceCitation: Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15. doi: 10.3810/pgm.2009.05.1997.

title: Adding Liraglutide to Oral Antidiabetic Drug Monotherapy: Efficacy and Weight Benefits

ReferenceCitation: McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998. Review.

ReferenceCitation: Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x. Review.

ReferenceCitation: Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.

ReferenceCitation: Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes ≥65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.

ReferenceCitation: Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13.

ReferenceCitation: Hegedüs L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.

name: Department of Endocrinology (L.H.), Odense University Hospital, 5000 Odense, Denmark;

name: Novo Nordisk Inc. (A.C.M.), Princeton, New Jersey 08540;

name: Novo Nordisk A/S (M.Z., T.L.T.), 2880 Bagsværd, Denmark;

name: Thyroid Unit (G.H.D.), Endocrine Tumor Center and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts 02114

title: GLP-1 and Calcitonin Concentration in Humans: Lack of Evidence of Calcitonin Release from Sequential Screening in over 5000 Subjects with Type 2 Diabetes or Nondiabetic Obese Subjects Treated with the Human GLP-1 Analog, Liraglutide

ReferenceCitation: Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

ReferenceCitation: Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

ReferenceCitation: Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

ReferenceCitation: King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

ReferenceCitation: Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.

location_country:
Finland
Malaysia
Greece
Romania
Australia
Czech Republic
Taiwan
India
Croatia
France
Poland
Thailand
Argentina
Korea, Republic of
South Africa
Switzerland
Philippines
Bulgaria
Italy
Brazil
Israel
Spain
Turkey


title: A 6-month Randomized, Double-blind, Parallel-group, Multicentre, Placebo-controlled Phase II Study to Compare Anti-asthmatic Effect and Safety of Esomeprazole (Nexium®) 40 mg Twice Daily or 40 mg Once Daily With Placebo in Adults With Asthma

acronym: RELAX

summary: The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.

ReferenceCitation: Kiljander TO, Junghard O, Beckman O, Lind T. Effect of esomeprazole 40 mg once or twice daily on asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2010 May 15;181(10):1042-8. doi: 10.1164/rccm.200910-1537OC. Epub 2010 Jan 28.

family: Kiljander

full_name: Toni O. Kiljander

given: Toni O.

family: Junghard

full_name: Ola Junghard

given: Ola

family: Beckman

full_name: Ola Beckman

family: Lind

full_name: Tore Lind

given: Tore

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Effect of Esomeprazole 40 mg Once or Twice Daily on Asthma

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Switzerland
Mexico
Germany
France
Bulgaria
Poland
Slovakia
Hungary
Argentina
Portugal
Canada
Czech Republic


title: A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)

summary: Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

location_country:
Italy
Austria
Sweden
Netherlands
Germany
France
Norway
Australia
Belgium
Spain
Denmark
United States
United Kingdom


title: A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.

summary: The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.

ReferenceCitation: Fleischhacker WW, Heikkinen ME, Olié JP, Landsberg W, Dewaele P, McQuade RD, Loze JY, Hennicken D, Kerselaers W. Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial. Int J Neuropsychopharmacol. 2010 Sep;13(8):1115-25. doi: 10.1017/S1461145710000490. Epub 2010 May 12.

family: Fleischhacker

full_name: W. Wolfgang Fleischhacker

given: W. Wolfgang

family: Heikkinen

full_name: Martti E. Heikkinen

given: Martti E.

family: Olié

full_name: Jean-Pierre Olié

given: Jean-Pierre

family: Landsberg

full_name: Wally Landsberg

given: Wally

family: Dewaele

full_name: Patricia Dewaele

given: Patricia

family: McQuade

full_name: Robert D. McQuade

given: Robert D.

family: Loze

full_name: Jean-Yves Loze

given: Jean-Yves

family: Hennicken

full_name: Delphine Hennicken

given: Delphine

family: Kerselaers

full_name: Wendy Kerselaers

given: Wendy

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Austria
South Africa
Sweden
Switzerland
United Kingdom
Finland
France
Poland
Hungary
Turkey
Germany
Czech Republic


title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients

acronym: IMPACT

summary: This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

ReferenceCitation: Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.

family: Humar

full_name: A. Humar

given: A.

family: Lebranchu

full_name: Y. Lebranchu

given: Y.

family: Vincenti

full_name: F. Vincenti

given: F.

family: Blumberg

full_name: E. A. Blumberg

given: E. A.

family: Punch

full_name: J. D. Punch

given: J. D.

family: Limaye

full_name: A. P. Limaye

given: A. P.

family: Abramowicz

full_name: D. Abramowicz

given: D.

family: Jardine

full_name: A. G. Jardine

given: A. G.

family: Voulgari

full_name: A. T. Voulgari

given: A. T.

family: Ives

full_name: J. Ives

family: Hauser

full_name: I. A. Hauser

given: I. A.

family: Peeters

full_name: P. Peeters

given: P.

journal_name: American Journal of Transplantation

repository_institution: University of Michigan - Deep Blue

title: The Efficacy and Safety of 200 Days Valganciclovir Cytomegalovirus Prophylaxis in High-Risk Kidney Transplant Recipients

location_country:
Italy
United States
Brazil
Germany
France
Poland
Romania
Belgium
Australia
New Zealand
Spain
Canada
United Kingdom

location_facility: Uni of Texas Health Science Center At San Antonio; Organ Transplant Program

location_facility: Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto

location_facility: Hospital Universitario Dr. Peset; Servicio de Nefrologia

location_facility: Institutul de Urologie Si Transplant Renal Cluj Napoca

location_facility: Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Western Infirmary; Division of Cardiovascular and Medical Sciences

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre

location_facility: Royal Prince Alfred Hospital; Renal Transplant Unit

location_facility: Hospital de Cruces; Servicio de Enfermedades Infecciosas

location_facility: Monash Medical Centre; Renal Transplant Unit

location_facility: Robert Wood Johnson Uni Hospital; Anesthesia

location_facility: Royal Liverpool Uni Hospital; Renal Dept

location_facility: Uni of California San Francisco; Transplant Services

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie

location_facility: Auckland City Hospital; Renal Unit, Level 15

location_facility: Churchill Hospital; Oxford Transplant Center Renal Transplant Unit

location_facility: Wake Forest Uni School of Medicine; Section on Infectious Diseases

location_facility: Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie

location_facility: Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej

location_facility: Nottingham City Hospital; Transplant Unit

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I

location_facility: Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique

location_facility: Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii

location_facility: Institutul de Urologie Si Transplant Renal Fundeni

location_facility: Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive

location_facility: New England Medical Center; Division of Transplant Surgery

location_facility: Hospital Israelita Albert Einstein; Intensive Care Unit

location_facility: Klinikum der Universitaet Regensburg; Nephrologie

location_facility: POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo

location_facility: Med. Hochschule Hannover Zentrum Chirurgie Klinik f.Allgemein- Viszeral- und Transplantationschirur

location_facility: Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin

location_facility: Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program

location_facility: CHU de Toulouse, Hopital Rangueil; Nephrologie-Tranplantation

location_facility: Ucsd Medical Center; Kidney Transplantation

location_facility: Uni of Minnesota Medical Center; Dept of Surgery

location_facility: Manchester Royal Infirmary; Renal Transplant Unit

location_facility: Klinik Johann Wolfgang von Goethe Uni; Innere Medizin - Dialyse

location_facility: Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj

location_facility: Uni of Washington Medical Center; Division of Allergy & Infectious Diseases

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi

location_facility: Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio

location_facility: Hopital Pellegrin; Departement Nephrologie

location_facility: Hopital Bretonneau; Nephrologie Transplantations

location_facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Enfermedades Infecciosas

location_facility: Oregon Health Sciences Uni ; Division of Nephrology

location_facility: Indiana Uni Medical Center; Surgery & Microbiology/Immunology


title: A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

summary: The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.

ReferenceCitation: Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

name: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman,...

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Hodi

full_name: F. Stephen Hodi

given: F. Stephen

family: Robert

full_name: Caroline Robert

given: Caroline

family: Weber

full_name: Jeffrey S. Weber

given: Jeffrey S.

family: Margolin

full_name: Kim Margolin

given: Kim

family: Hamid

full_name: Omid Hamid

given: Omid

family: Patt

full_name: Debra Patt

given: Debra

family: Chen

full_name: Tai-Tsang Chen

given: Tai-Tsang

family: Berman

full_name: David M. Berman

given: David M.

family: Wolchok

full_name: Jedd D. Wolchok

given: Jedd D.

journal_name: Journal of Clinical Oncology

publisher_group: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbé C. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010 Feb;11(2):155-64. doi: 10.1016/S1470-2045(09)70334-1. Epub 2009 Dec 8.

full_name: Jedd D Wolchok

given: Jedd D

family: Neyns

full_name: Bart Neyns

given: Bart

family: Linette

full_name: Gerald Linette

given: Gerald

family: Negrier

full_name: Sylvie Negrier

given: Sylvie

family: Lutzky

full_name: Jose Lutzky

given: Jose

family: Thomas

full_name: Luc Thomas

given: Luc

family: Waterfield

full_name: William Waterfield

given: William

family: Smylie

full_name: Michael Smylie

given: Michael

location_country:
United States
Brazil
South Africa
Germany
France
Hungary
Belgium
Australia
Canada
Czech Republic

location_facility: The Angeles Clinic And Research Institution

location_facility: Center For Oncology Research & Treatment, P.A.

location_facility: Harry And Jeanette Weinberg Cancer Inst At Franklin Square

location_facility: The Christ Hospital Cancer Center Research

location_facility: Washington University School Of Medicine


title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

summary: Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.

lead_sponsor: Eisai Limited

location_country:
Italy
Austria
South Africa
Sweden
Serbia
United Kingdom
Spain
France
Poland
Lithuania
Israel
Hungary
Belgium
Portugal
Estonia
Germany
Czech Republic

location_facility: LMU Munchen, Neurologische Universitatsklinik

location_facility: Universitatsklinik Lubeck Klinik fur Neurologie Ratzeburger Allee 160 D-23538 Lubeck

location_facility: Uni-klinikum Charite, Campus Virchow-klinikum

location_facility: Vilnius University Hospital, Santariskiu Clinic

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska, Gabinet Neur

location_facility: Centre d'Investigation Clinique, Hospital Purpan

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Centre de Pharmacologie Clinique et Evaluation Therapeutique