lead_sponsor: Genzyme, a Sanofi Company

summary: The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.

ReferenceCitation: Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. doi: 10.1200/JCO.2011.35.5040. Epub 2011 Oct 24. Erratum In: J Clin Oncol. 2013 Aug 20;31(24):3049.

location_facility:
Investigational Site Number 2701
Investigational Site Number 2005
Investigational Site Number 1001
Investigational Site Number 2506
Investigational Site Number 14
Investigational Site Number 1702
Investigational Site Number 2403
Investigational Site Number 1801
Investigational Site Number 1203
Investigational Site Number 17
Investigational Site Number 1601
Investigational Site Number 13
Investigational Site Number 15
Investigational Site Number 19
Investigational Site Number 2901
Investigational Site Number 2602
Investigational Site Number 11
Investigational Site Number 2404
Investigational Site Number 9
Investigational Site Number 2002
Investigational Site Number 3001
Investigational Site Number 3
Investigational Site Number 18
Investigational Site Number 3402
Investigational Site Number 3301
Investigational Site Number 2102
Investigational Site Number 1205
Investigational Site Number 2505
Investigational Site Number 2902
Investigational Site Number 2301
Investigational Site Number 3003
Investigational Site Number 2402
Investigational Site Number 3102
Investigational Site Number 1101
Investigational Site Number 1701
Investigational Site Number 8
Investigational Site Number 6
Investigational Site Number 22
Investigational Site Number 3601
Investigational Site Number 2001
Investigational Site Number 1501
Investigational Site Number 2801
Investigational Site Number 1102
Investigational Site Number 2504
Investigational Site Number 10
Investigational Site Number 1201
Investigational Site Number 2302
Investigational Site Number 1703
Investigational Site Number 2503
Investigational Site Number 2601
Investigational Site Number 2502
Investigational Site Number 7
Investigational Site Number 21
Investigational Site Number 1202
Investigational Site Number 2802
Investigational Site Number 2803
Investigational Site Number 3401
Investigational Site Number 1204
Investigational Site Number 2101
Investigational Site Number 1901
Investigational Site Number 2
Investigational Site Number 3002
Investigational Site Number 1401
Investigational Site Number 1402
Investigational Site Number 3101
Investigational Site Number 2501

status: Active, not recruiting

title: An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer

study_completion_date_type: Anticipated

location_country:
Germany
Poland
Australia
Brazil
Czechia
Canada
Serbia
France
Portugal
Hungary
Denmark
Switzerland
United States
India
Romania
Belgium
Italy
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Russian Federation
Sweden

status_simplified: Ongoing


title: A 10-week Randomised, DB, PG, PC Phase 2 Study to Investigate the Extent of Symptom Relief and the Safety and Tolerability of SMP-986 (20, 40, 80 and 120 mg) Administered Once Daily for 8 Weeks to Patients With Overactive Bladder Syndrome

summary: SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with SMP-986 compared to placebo, as well comparing the change in: the severity of urgency episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr and the mean void volume/void between SMP-986 and placebo.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Sumitomo Pharma America, Inc.

sponsor_collaborators:
Sumitomo Pharma America, Inc.
Dainippon Sumitomo Pharma America
ICON Clinical Research
ClinPhone, Inc.
Covance
PPD

location_country:
Germany
Lithuania
Poland
United Kingdom
United States
Latvia
Spain
Estonia
France

location_facility: San Bernadino Urological Association Medical Group

location_facility: Gem. Praxis fur Urologie und Mannerheilkunde

location_facility: Clinical Dept of Urology, Medical Postgraduate Education

location_facility: Southern Research Group, Centre Point Boulevard

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Controlled, Double-Blind, Randomised, Dose-Ranging Study on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXa-HIP2 Study BAY 59-7939

summary: Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied by injections below the skin. The purpose of this study was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated phase III trials. Enoxaparin, a so-called low molecular weight heparin, is approved and widely used in the area of thromboprophylaxis and was given once daily subcutaneously. In this study 5 different doses of the investigational drug BAY 59-7939 were tested in comparison to Enoxaparin. The following doses of BAY 59-7939 were tested: 2.5 mg twice daily (5 mg total daily dose); 5 mg twice daily (10 mg total daily dose), 10 mg twice daily (20 mg total daily dose), 20 mg twice daily (40 mg total daily dose) and 30 mg twice daily ( 60 mg total daily dose). This study ran for approximately 7 months in a number of countries. In total, 726 patients were enrolled in this study.

primary_purpose: Prevention

lead_sponsor: Bayer

location_country:
Germany
Italy
Poland
Israel
Norway
Denmark
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
France


title: Randomised,Double-blind,Placebo-controlled,Parallel Group Study TroVax, Added to First-line Standard of Care, Prolongs Survival of Patients With Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma.

summary: The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma.

ReferenceType: result

ReferenceCitation: Amato RJ, Hawkins RE, Kaufman HL, Thompson JA, Tomczak P, Szczylik C, McDonald M, Eastty S, Shingler WH, de Belin J, Goonewardena M, Naylor S, Harrop R. Vaccination of metastatic renal cancer patients with MVA-5T4: a randomized, double-blind, placebo-controlled phase III study. Clin Cancer Res. 2010 Nov 15;16(22):5539-47. doi: 10.1158/1078-0432.CCR-10-2082. Epub 2010 Sep 29.

lead_sponsor: Oxford BioMedica

sponsor_collaborators:
Oxford BioMedica
Sanofi

location_country:
Germany
France
Poland
United Kingdom
Romania
United States
Spain
Ukraine
Russian Federation
Israel

location_facility: State Higher Educational Institution: Siberian State Medical University, Department of Urology

location_facility: Regional State Medical Institution:"Orel Oncological Center", Oncology Department #5

location_facility: Rostov State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology

location_facility: Chelyabinsk Regional Oncological Center, Chemotherapy Department

location_facility: The Angeles Clinic and Reseach Institute

location_facility: Non-State Medical Institution:Central Clinical Hospital

location_facility: Dnepropetrovsk State Medical Academy, Department of Urology

location_facility: Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center

location_facility: Municipal Medical Institution: Oncological Center, Chemotherapy Department

location_facility: Independent Public Clinical Hospital #2 - Pomeranian Medical Academy in Szczecin, Urology Clinic

location_facility: Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Radiology Daignostics and Radiology Therapy

location_facility: IIndependent Public Hospital #1- , Oncology and Radiotherapy Dept

location_facility: Maria Sklodowska-Curie Memorial Institute, Oncology Center in Warsaw, Clinic of Neoplasms of Urinary System

location_facility: Henry Ford Health System / Josephine Ford Cancer Center

location_facility: State Medical Institution: Tambov Regional Oncological Center, Surgery Department

location_facility: Leningrad Regional Oncological Center, Surgical Department #3

location_facility: Holycross Oncology Center in Kielce, Department of Urology

location_facility: Samara Regional Oncology Center, Chemotherapy Department

location_facility: Kharkov Regional Clinical Urology and Nephrology Center, Oncourology Department

location_facility: Medical Radiological Research Center under the Russian Academy of Medical Sciences, Department of Urology

location_facility: Little Rock Hematology / Oncology Associates, P.A.

location_facility: Military Institute of Medicine, Department of Oncology

location_facility: Urology Institute under the Ukrainian Academy of Medical Sciences, Plastic and Reconstructive Urology Department

location_facility: Urology Institute under the Ukrainian Academy of Medical Sciences, Oncourology Department

location_facility: Lugansk Regional Clinical Oncological Center, Urology Department

location_facility: Department of Biotherapy and Bone Marrow Transplantation

location_facility: Independent Public Health Care Institution University Hospital in Krakow, Department of Oncology

location_facility: Municipal Hospital #26, Department Of Urology

location_facility: Pyatigorsk Branch of Stavropol Territorial Clinical Oncological Center (State Medical Institution), Outpatient Department

location_facility: University Minnesota Fairview Medical Center

location_facility: Lord's Transfiguration Independent Hospital Medical Academy Poznań

location_facility: Murmansk Regional Oncological Center, Oncology Department #5

location_facility: Hospital Santa Creu i Sant Pau Hospital Nuevo-Servicio de Oncologia Medica

location_facility: Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department

location_facility: St Luke's Cancer Centre, Royal Surrey County Hospital

location_facility: "Oncological Center", Department of Haematology and Chemotherapy

location_facility: Heamatology and Oncology Associates Inc.

location_facility: Regional Specialistic Hospital in Wrocław, Department of Urology

location_facility: Sibiu Clinical County Hospital - Urology Clinic

location_facility: State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center,

location_facility: Regional Public Institution: Krivoy Rog Oncological Center, Chemotherapy Department

location_facility: Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology and Surgical Nephrology

location_facility: Orenburg Regional Clinical Oncological Center, Chemotherapy Department

location_facility: Moscow Research Oncological Institute n.a. P.A. Hertzen, Urology Departmen

location_facility: Donetsk Regional Antitumor Center, Urology Department

location_facility: Oncology institute , The Chaim Sheba Medical center

location_facility: State Medical Institution: Omsk Regional Oncological Center, Chemotherapy Department

location_facility: Bashkir State Medical University, Urology Department

location_facility: Zaporozhye Medical Academy of Postgraduate Education, Urology Department

location_facility: Crimea State Medical University n.a. S.I. Georgievsky, Course in Urology at the Faculty Surgery#1 Department

location_facility: Oncology department, Assaf Harofeh Medical Center

location_facility: Charleston Hematology and Oncology Associates,

location_facility: Ivano-Frankovsk State Medical University; Oncology Department

location_facility: Maria Sklodowska-Curie Memorial Institute, Oncology Center Kraków Clinic Systemic and Generalized Neoplasms

location_facility: Municipal Multi-Speciality Hospital #2, Department of Urology

location_facility: Haematology and Oncology Associates at Bridgeport

location_facility: Universitätsklinikum C.G. Carus TU Dresden

location_facility: Regional Research Clinical Institute n.a M.F. Vladimirskiy, Urology Department #1

location_facility: State Medical Institution of Yaroslavl Region

location_facility: St. Petersburg State Medical Institution: Municipal Hospital #15, Urology Department

location_facility: Zaporozhye Medical Academy of Postgraduate Education, Oncology Department

location_facility: St. Petersburg State Pediatric Medical Academy

location_facility: State Institution: Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences, Department of Urology

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: "Central Research Institute of Roentgenology & Radiology Federal Agency Healthcare Social Development"

location_facility: "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic

location_facility: Oncology institute , Rambam /health Care Campus

location_facility: St. Petersburg State Medical Institution: Municipal Multi-Speciality Hospital #2, Department of Functional Diagnostics

location_facility: Flower Hospital/ Promedica Health System

location_facility: Crimean Republican Clinical Oncological Center, Chemotherapy Department

location_facility: Oncology department Rabin Medical center

location_facility: Fundeni Clinical Institute - Urology Department

location_facility: Hospital Severo Ochoa, Servicio de Oncologia - Primera planta

location_facility: Russian Research Center of Roentgenology & Radiology , Surgery Department

location_facility: State Medical Institution of Healthcare: Clinical Oncological Center under the Ministry of Healthcare of the Republic of Tatarstan, Chemotherapy Department

location_facility: State Medical Institution: Stavropol Territorial Clinical Oncological Center, Department of Urology

location_facility: Bukovyna State Medical University, Department of Oncology, Radiodiagnostics and Radiotherapy

location_facility: State Medical Institution: Arkhangelsk Regional Clinical Oncological Center, Surgery Department 7.

location_facility: Dnepropetrovsk State Medical Academy, Oncology, Radiodiagnostics and Radiotherapy Department

location_facility: State Institution of Nizhny Novgorod Region: "Nizhny Novgorod Oncology Center", Department of Oncology #5 (for chemotherapy treatment)

location_facility: Republican Oncology Center" under the Ministry of Healthcare,

location_facility: State Institution of Mariy El Republic: "Republican Clinical Hospital", Department Of Urology

location_facility: Hospital Marques de Valdecilla Consultas de Oncologia 1st planta

intervention_type: Biological


title: Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

summary: The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Argentina
Australia
Brazil
United States
Korea, Republic of
Spain
Taiwan
France

location_facility:
Baylor University Medical Center
Mayo Clinic
University Of Nebraska Medical Center
Tulane University Hospital & Clinic
Northwestern University
Baylor College Of Medicine
Local Institution
Cleveland Clinic
University Of Rochester Medical Center
University Of Cincinnati Medical Center


title: A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy

summary: The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.

location_country:
Italy
Poland
Russian Federation
United Kingdom
Denmark
Australia
Belgium
United States
Korea, Republic of
Philippines
Spain
Greece
Thailand
Canada
Indonesia
France

location_facility: Acrc/Arizona Clinical Research Center, Inc.

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: University Of Missouri Healthcare/Ellis Fischel Cancer Ctr

location_facility: Hematology Oncology Centers Of The Northern Rockies, Pc

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: University Of Florida College Of Medicine At Jacksonville

location_facility: South Texas Oncology And Hematology, P.A.

location_facility: The Center For Cancer And Blood Disorders

location_facility: Carolinas Hematology Oncology Associates

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Capital Comprehensive Cancer Care Center

location_facility: University Of Texas Medical Branch Of Galveston

location_facility: Guthrie Foundation For Education And Research

location_facility: Glendale Memorial Hospital And Health Center

location_facility: Washington University School Of Medicine

location_facility: Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr


title: A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects

acronym: EAGER

summary: This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Colombia
Hungary
Israel
United Kingdom
Australia
Netherlands
Mexico
United States
Spain
Chile
Canada
France

location_facility: West Virginia University Health Sciences Center


title: Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer

summary: The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.

ReferenceType: background

ReferenceCitation: Yu EY, Wilding G, Posadas E, Gross M, Culine S, Massard C, Morris MJ, Hudes G, Calabro F, Cheng S, Trudel GC, Paliwal P, Sternberg CN. Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Dec 1;15(23):7421-8. doi: 10.1158/1078-0432.CCR-09-1691. Epub 2009 Nov 17.

location_country:
United States
Italy
France

location_facility: The Bunting Blaustein Cancer Research Building

location_facility: Memorial Sloan-Kettering Cancer Center-Sidney Kimmel Center

location_facility: University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr


type: Other Identifier

title: The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis

summary: The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Argentina
Australia
United States
Spain
Taiwan
Canada
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


lead_sponsor: Eisai Inc.

summary: The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.

ReferenceType: derived

ReferenceCitation: Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Rektor I, Krauss GL, Bar M, Biton V, Klapper JA, Vaiciene-Magistris N, Kuba R, Squillacote D, Gee M, Kumar D. Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. Acta Neurol Scand. 2012 Oct;126(4):263-9. doi: 10.1111/ane.12001. Epub 2012 Aug 23.

title: An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 (Perampanel) as an Adjunctive Therapy in Patients With Refractory Partial Seizures

source: euctr

location_country:
Finland
France
Germany
Lithuania
United Kingdom
Australia
Sweden
Netherlands
Belgium
United States
Latvia
Spain
Estonia
Czech Republic


acronym: ULD trial

lead_sponsor: UCB Pharma

summary: The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

repositories_concat: HAL

unpaywall_oa_status: hybrid

ReferenceCitation: Kalviainen R, Genton P, Andermann E, Andermann F, Magaudda A, Frucht SJ, Schlit AF, Gerard D, de la Loge C, von Rosenstiel P. Brivaracetam in Unverricht-Lundborg disease (EPM1): Results from two randomized, double-blind, placebo-controlled studies. Epilepsia. 2016 Feb;57(2):210-21. doi: 10.1111/epi.13275. Epub 2015 Dec 15.

oa_host_type: publisher

evidence: open (via free pdf)

license_normalized: no license

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (≥ 16 Years) With Genetically Ascertained Unverricht-Lundborg Disease

type: EudraCT Number

location_country:
Finland
France
Tunisia
United States
Canada
Serbia
Russian Federation
Israel


title: A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus

summary: To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus

status: Terminated

lead_sponsor: Pfizer

location_country:
Finland
Ireland
Portugal
Norway
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
United States
Spain
France

status_simplified: Unknown


title: An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

summary: To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: PDL BioPharma, Inc.

location_country:
France
Germany
Ireland
Italy
Hungary
Norway
Australia
Netherlands
Austria
Belgium
United States
Canada
Ukraine
Czech Republic


title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Morning Administration of GW679769 (10mg and 30 mg) on Polysomnograph Sleep Recordings, Subjective Sleep Assessment, Daytime Cognition and Psychomotor Function in Subjects With Primary Insomnia

summary: This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9 days, will promote sleep during the following night without significant post-dose thinking impairment and drowsiness in subjects with primary insomnia.

lead_sponsor: GlaxoSmithKline

location_country:
United States
Germany
France


title: DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311-E)

acronym: Darusentan

summary: This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
Argentina
Denmark
Brazil
Sweden
United States
Canada
France

location_facility: Centro Integrado Hospital do Rim e Hipertensao

location_facility: Hôpital Civil, Service HTA maladies vasculaires

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Castlerock Clinical Research Consultants

location_facility: Green and Seidner Family Practice Associates

location_facility: Cardiovascular Research, Karolinska Institue

location_facility: Northeast Clinical Research Centers, Inc.

location_facility: MedStar Diabetes Institute at Washington Hospital Center


acronym: EXTEND

summary: An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.

ReferenceCitation: Wong RSM, Saleh MN, Khelif A, Salama A, Portella MSO, Burgess P, Bussel JB. Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood. 2017 Dec 7;130(23):2527-2536. doi: 10.1182/blood-2017-04-748707. Epub 2017 Oct 17. Erratum In: Blood. 2018 Feb 8;131(6):709.

evidence: open (via free article)

publisher_dissemination: American Society of Hematology

ReferenceCitation: Tarantino MD, Fogarty P, Mayer B, Vasey SY, Brainsky A. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. Blood Coagul Fibrinolysis. 2013 Apr;24(3):284-96. doi: 10.1097/MBC.0b013e32835fac99.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Saleh MN, Bussel JB, Cheng G, Meyer O, Bailey CK, Arning M, Brainsky A; EXTEND Study Group. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia: results of the long-term, open-label EXTEND study. Blood. 2013 Jan 17;121(3):537-45. doi: 10.1182/blood-2012-04-425512. Epub 2012 Nov 20.

ReferenceCitation: Fogarty PF, Tarantino MD, Brainsky A, Signorovitch J, Grotzinger KM. Selective validation of the WHO Bleeding Scale in patients with chronic immune thrombocytopenia. Curr Med Res Opin. 2012 Jan;28(1):79-87. doi: 10.1185/03007995.2011.644849. Epub 2011 Dec 20.

ReferenceCitation: Signorovitch J, Brainsky A, Grotzinger KM. Validation of the FACIT-fatigue subscale, selected items from FACT-thrombocytopenia, and the SF-36v2 in patients with chronic immune thrombocytopenia. Qual Life Res. 2011 Dec;20(10):1737-44. doi: 10.1007/s11136-011-9912-9. Epub 2011 May 1.

location_facility:
Novartis investigative Site
Novartis Investigative Site

title: EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study.

location_country:
Finland
Germany
Poland
New Zealand
Australia
Thailand
Vietnam
Pakistan
Canada
France
Czech Republic
Slovenia
Slovakia
Hong Kong
Denmark
United States
Ukraine
Romania
Tunisia
China
Peru
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


title: A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder

summary: The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.

lead_sponsor: Solvay Pharmaceuticals

collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
France
Lithuania
Hungary
Argentina
United States
Latvia
Canada
Estonia
Czech Republic

location_facility:
Site 127
Site 204
Site 231
Site 153
Site 222
Site 223
Site 226
Site 232
Site 229
Site 174
Site 109
Site 124
Site 159
Site 179
Site 133
Site 115
Site 138
Site 218
Site 122
Site 162
Site 305
Site 209
Site 187
Site 152
Site 170
Site 233
Site 169
Site 303
Site 206
Site 185
Site 190
Site 121
Site 126
Site 154
Site 164
Site 208
Site 210
Site 197
Site 128
Site 235
Site 228
Site 225
Site 216
Site 301
Site 151
Site 111
Site 112
Site 102
Site 217
Site 134
Site 148
Site 177
Site 163
Site 172
Site 141
Site 145
Site 180
Site 107
Site 136
Site 101
Site 236
Site 219
Site 176
Site 110
Site 203
Site 220
Site 306
Site 193
Site 130
Site 234
Site 191
Site 117
Site 205
Site 116
Site 196
Site 183
Site 146
Site 215
Site 307
Site 100
Site 181
Site 165
Site 147
Site 129
Site 202
Site 131
Site 189
Site 213
Site 230
Site 184
Site 304
Site 195
Site 166
Site 175
Site 167
Site 308
Site 214
Site 182
Site 212
Site 194
Site 207
Site 140
Site 173
Site 171
Site 198
Site 302
Site 104
Site 142
Site 178
Site 201
Site 186
Site 156
Site 168
Site 221
Site 114
Site 224
Site 106
Site 211
Site 113
Site 161
Site 108
Site 188


lead_sponsor: AstraZeneca

summary: The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma

title: A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients With Unresectable AJCC Stage 3 or 4 Malignant Melanoma

location_country:
United Kingdom
Argentina
Denmark
Australia
Brazil
Switzerland
Austria
United States
Canada
France


study_start_date_type: Actual

summary: The purpose of this study is to compare E7389 versus capecitabine in patients with locally advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive either E7389 or capecitabine on a one-to-one ratio.

ReferenceCitation: Twelves C, Awada A, Cortes J, Yelle L, Velikova G, Olivo MS, Song J, Dutcus CE, Kaufman PA. Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer. Breast Cancer (Auckl). 2016 Jun 28;10:77-84. doi: 10.4137/BCBCR.S39615. eCollection 2016.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

version: submittedVersion

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

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

repository_normalized: dnet

repositories:
PubMed Central
dnet
eprints.whiterose.ac.uk

unpaywall_oa_status: gold

publisher_dissemination: SAGE Publications

ReferenceCitation: Cortes J, Hudgens S, Twelves C, Perez EA, Awada A, Yelle L, McCutcheon S, Kaufman PA, Forsythe A, Velikova G. Health-related quality of life in patients with locally advanced or metastatic breast cancer treated with eribulin mesylate or capecitabine in an open-label randomized phase 3 trial. Breast Cancer Res Treat. 2015 Dec;154(3):509-20. doi: 10.1007/s10549-015-3633-7. Epub 2015 Nov 14.

evidence: open (via page says license)

publisher_dissemination: Springer-Nature

ReferenceCitation: Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Twelves C, Cortes J, Kaufman PA, Yelle L, Awada A, Binder TA, Olivo M, Song J, O'Shaughnessy JA, Jove M, Perez EA. "New" metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy. Breast Cancer Res. 2015 Dec 9;17(1):150. doi: 10.1186/s13058-015-0657-1.

ReferenceCitation: Twelves C, Cortes J, Vahdat LT, Wanders J, Akerele C, Kaufman PA. Phase III trials of eribulin mesylate (E7389) in extensively pretreated patients with locally recurrent or metastatic breast cancer. Clin Breast Cancer. 2010 Apr;10(2):160-3. doi: 10.3816/CBC.2010.n.023.

location_facility: Pecsi Tudomanyegyetem, Onkoterapias Intezet

location_facility: Augusta-Kranken-Anstalt, Klinik fur Hamatologie und Onkologie

location_facility: Centre Hospitalier Universitaire de Montreal, Hopital Notre Dame

location_facility: Thunder Bay Regional Health Science Centre Northwestern Ontario

location_facility: Instituto Argentino de Diagnostico y Tratamiento

location_facility: Instituto Ribeiraopretano de Combate ao Cancer

location_facility: Hospital das Clinicas de Faculdade de Medicina da Universidade de Sao

location_facility: Institut Jules Bordet, Medical Oncology Unit

location_facility: Centre Hosptialier Universitaire Sart Tilman Liege

location_facility: Hospital do Cancer de Sao Paulo-AC Camargo

location_facility: Hospital do Cancer de Sao Paulo-AC. Camargo

location_facility: Bankstown Hospital, Oncology Trials Unit

location_facility: Centre Hospitalier La Roche sur Yon, CHD les Oudairies

location_facility: Hospital de Clinicas de Porto Alegre, Servicio de Oncologia

location_facility: Hospital General de Agudos Teodoro Alvarez

location_facility: Servico de Quimioterapia de Pernambuco-SEQUIPE

location_facility: Grupo Paulista de Oncologia Integrada Ltda

location_facility: Liverpool Hospital, Cancer Therapy Centre

location_facility: CHU de Poitiers, Service d'Oncologie Medicale

location_facility: Instituto Brasileiro de Controle do Cancer-IBCC

location_facility: Sir Charles Gairdner Hospital, Dept. of Medical Oncology

title: A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

location_country:
Germany
Poland
Argentina
Australia
Brazil
Czechia
Canada
France
Hungary
United States
Ukraine
Romania
Belgium
Italy
Singapore
Mexico
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.

summary: This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

ReferenceCitation: Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3.

location_country:
Germany
Italy
Lithuania
Poland
India
Portugal
United Kingdom
Australia
Netherlands
United States
Spain
Thailand
Malaysia
South Africa
Taiwan
Estonia
Czech Republic
France


title: A Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH®, MabCampath®) in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia

summary: This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for patients with relapsed or refractory B-CLL who have been previously treated.

collaborators: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

location_country:
United Kingdom
Belgium
United States
Serbia
Czech Republic
France

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Royal Liverpool and Broadgreen Hospitals

location_facility: North Mississippi Hematology & Oncology Associates, Ltd.

location_facility: Institute of Hematology, Clinical Centre of Serbia

location_facility: University Hospital Hradec Kralove (UH HK)

location_facility: Clinic of Hematology, Clinical Centre Vojvodina Novi Sad

location_facility: University of Colorado Cancer Center at University of Colorado Health Sciences Center

location_facility: Hopital Hotel-Dieu, CHU de Nantes-Service d'Hematologie Clinique


title: A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)

summary: To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.

ReferenceCitation: Vizza CD, Jansa P, Teal S, Dombi T, Zhou D. Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial. BMC Cardiovasc Disord. 2017 Sep 6;17(1):239. doi: 10.1186/s12872-017-0674-3.

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central;iris.uniroma1.it

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Germany
Italy
Israel
United Kingdom
Australia
United States
Greece
Taiwan
Czechia
France

location_facility: II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie

location_facility: Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig

location_facility: Med. Klinik u. Poliklinik I der LMU Muenchen, Klinikum Grosshadern

location_facility: Universitaetsklinikum des Saarlandes, Innere Medizin V

location_facility: West Los Angeles VA Healthcare, Pulmonary Hypertension Program

location_facility: Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin

location_facility: Missionsaerztliche Klinik Wuerzburg, Gemeinnuetzige Gesellschaft mbH

location_facility: Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie

location_facility: Institut klinicke a experimentalni mediciny, Klinika kardiologie

location_facility: Department of Surgery, National Taiwan University Hospital

location_facility: Cardiologia, Azienda Ospedaliera Monaldi, Seconda Università di Napoli

location_facility: Praxis fuer Innere Medizin, Kardiologie und Angiologie

location_facility: Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen

location_facility: Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari


title: A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients

summary: The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.

ReferenceCitation: Touraine P, D'Souza GA, Kourides I, Abs R, Barclay P, Xie R, Pico A, Torres-Vela E, Ekman B; GH Lipoatrophy Study Group. Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH. Eur J Endocrinol. 2009 Oct;161(4):533-40. doi: 10.1530/EJE-09-0422. Epub 2009 Aug 4.

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


title: A Phase 1/2 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With Follicular Or Diffuse Large B-cell Non-hodgkin's Lymphoma

summary: The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin [CMC-544] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

ReferenceCitation: Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Gine E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. doi: 10.1200/JCO.2012.42.7211. Epub 2013 Jan 7.

oa_colors: green other

repositories_concat: PubMed Central

sponsor_collaborators:
Pfizer
UCB Pharma

location_country:
Germany
Italy
Poland
United Kingdom
Hong Kong
Australia
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Spain
France

location_facility: Universitaetsklinik Bonn, Medizinische Klinik und Poliklinik III

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Universita La Sapienza Cattedra di Ematologia

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet, III. medizinische klinik und Poliklinik

location_facility: Emory University Investigational Drug Service

location_facility: University Hospital Gent - Department of Hematology

location_facility: Bart's Cancer Institute; Queen Mary University of London


title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease

summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.

ReferenceCitation: Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4.

location_country:
France
Germany
United Kingdom
Argentina
Denmark
Australia
Brazil
Netherlands
Mexico
United States
Korea, Republic of
Greece
Taiwan
Canada
Czech Republic


title: A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures

summary: The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.

ReferenceCitation: Kwan P, Brodie MJ, Kalviainen R, Yurkewicz L, Weaver J, Knapp LE. Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol. 2011 Oct;10(10):881-90. doi: 10.1016/S1474-4422(11)70154-5. Epub 2011 Aug 31.

sponsor_collaborators: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Finland
Germany
Ireland
Thailand
Czechia
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Latvia
India
Romania
Belgium
China
Estonia
Italy
Norway
Singapore
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Sweden


title: A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

summary: The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

lead_sponsor: Facet Biotech

sponsor_collaborators:
Facet Biotech
PDL BioPharma, Inc.

location_country:
France
Germany
Italy
Hungary
Israel
Norway
Australia
Netherlands
Austria
Belgium
United States
Croatia
Canada
Ukraine
Czech Republic


title: A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

acronym: FIRST

summary: The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.

location_country:
Italy
Poland
United Kingdom
Brazil
United States
Spain
Czechia
Bulgaria
France


title: A Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Efficacy of Controlled-release Ropinirole (CR) (1-24 mg) Administered Once Daily for 12 Weeks in Subjects With Fibromyalgia

summary: A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. A total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 European countries. Male and female subjects greater than 18 years of age with a diagnosis of primary fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon a statistically defined allocation to treatment. The primary endpoint is improvement in pain score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the subject's pain is being collected on a daily diary. In addition, the overall improvement in quality of life for the subject will be assessed by means of a number of subject-completed questionnaires during the treatment period. Safety of the treatment regimen will be assessed throughout the study.

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.

location_country:
Finland
Germany
Italy
United Kingdom
Denmark
Sweden
Netherlands
Belgium
France


title: A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma

summary: CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.

location_country:
Germany
Italy
United Kingdom
Argentina
Australia
United States
Spain
Canada
France

location_facility:
Research Site
Pfizer Investigational Site


title: A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer

summary: The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.

ReferenceCitation: Bachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166.

publisher_dissemination: Springer

location_country:
Belgium
United States
Spain
Canada
France


title: A Phase III, Multicentre, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.

summary: This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.

ReferenceCitation: Gunasekaran T, Tolia V, Colletti RB, Gold BD, Traxler B, Illueca M, Crawley JA. Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study. BMC Gastroenterol. 2009 Nov 18;9:84. doi: 10.1186/1471-230X-9-84.

location_country:
United States
Italy
Canada
France


title: Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol

summary: The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Hungary
United Kingdom
Romania
Netherlands
South Africa
Croatia
Canada
Czech Republic
Russian Federation
France


title: A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.

summary:
To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.

To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the lining of the food pipe.

To collect information that will describe the psychological, social, and economic effects on the primary caregiver of raising children ages 1 to 5 years old with GERD.

ReferenceCitation: Tolia V, Gilger MA, Barker PN, Illueca M. Healing of Erosive Esophagitis and Improvement of Symptoms of Gastroesophageal Reflux Disease After Esomeprazole Treatment in Children 12 to 36 Months Old. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S31-6. doi: 10.1097/MPG.0b013e3181ddcf11.

ReferenceCitation: Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S24-30. doi: 10.1097/01.mpg.0000469419.29000.94.

ReferenceCitation: Tolia V, Gilger MA, Barker PN, Illueca M. Healing of erosive esophagitis and improvement of symptoms of gastroesophageal reflux disease after esomeprazole treatment in children 12 to 36 months old. J Pediatr Gastroenterol Nutr. 2010 Nov;51(5):593-8. doi: 10.1097/MPG.0b013e3181ddcf11.

ReferenceCitation: Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study. BMC Pediatr. 2010 Jun 11;10:41. doi: 10.1186/1471-2431-10-41.

ReferenceCitation: Gilger MA, Tolia V, Vandenplas Y, Youssef NN, Traxler B, Illueca M. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2008 May;46(5):524-33. doi: 10.1097/MPG.0b013e318176b2cb.

location_country:
United States
Italy
Belgium
France


title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects With Severe Persistent Asthma

summary: The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.

ReferenceCitation: Wenzel SE, Barnes PJ, Bleecker ER, Bousquet J, Busse W, Dahlen SE, Holgate ST, Meyers DA, Rabe KF, Antczak A, Baker J, Horvath I, Mark Z, Bernstein D, Kerwin E, Schlenker-Herceg R, Lo KH, Watt R, Barnathan ES, Chanez P; T03 Asthma Investigators. A randomized, double-blind, placebo-controlled study of tumor necrosis factor-alpha blockade in severe persistent asthma. Am J Respir Crit Care Med. 2009 Apr 1;179(7):549-58. doi: 10.1164/rccm.200809-1512OC. Epub 2009 Jan 8.

lead_sponsor: Centocor, Inc.

sponsor_collaborators:
Centocor, Inc.
Centocor BV

location_country:
Germany
Poland
Hungary
United Kingdom
Sweden
Netherlands
Belgium
United States
Bulgaria
Czech Republic
France


title: Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women

summary: The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.

ReferenceCitation: Christiansen C, Chesnut CH 3rd, Adachi JD, Brown JP, Fernandes CE, Kung AW, Palacios S, Levine AB, Chines AA, Constantine GD. Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis. BMC Musculoskelet Disord. 2010 Jun 22;11:130. doi: 10.1186/1471-2474-11-130.

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Croatia
Chile
Canada
France
Lithuania
Slovakia
Hungary
Hong Kong
Denmark
United States
Romania
Belgium
Estonia
Italy
Norway
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Bulgaria
Russian Federation


title: Establishment of Baseline and Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System

summary: The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates of ventriculostomy-related infection between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized open label study

ReferenceCitation: Codman in house testing reports, TR2213 and PVER99-133 Addendum

ReferenceCitation: Bayston R. Hydrocephalus Shunt Infections. Chapman and Hall Medical, London, 1989, p. 23.

ReferenceCitation: Bayston R, Grove N, Siegel J, Lawellin D, Barsham S. Prevention of hydrocephalus shunt catheter colonisation in vitro by impregnation with antimicrobials. J Neurol Neurosurg Psychiatry. 1989 May;52(5):605-9. doi: 10.1136/jnnp.52.5.605.

ReferenceCitation: Bayston R, Lambert E. Duration of protective activity of cerebrospinal fluid shunt catheters impregnated with antimicrobial agents to prevent bacterial catheter-related infection. J Neurosurg. 1997 Aug;87(2):247-51. doi: 10.3171/jns.1997.87.2.0247.

ReferenceCitation: Govender ST, Nathoo N, van Dellen JR. Evaluation of an antibiotic-impregnated shunt system for the treatment of hydrocephalus. J Neurosurg. 2003 Nov;99(5):831-9. doi: 10.3171/jns.2003.99.5.0831.

ReferenceCitation: Lozier AP, Sciacca RR, Romagnoli MF, Connolly ES Jr. Ventriculostomy-related infections: a critical review of the literature. Neurosurgery. 2002 Jul;51(1):170-81; discussion 181-2. doi: 10.1097/00006123-200207000-00024.

ReferenceCitation: Schierholz J, Jansen B, Jaenicke L, Pulverer G. In-vitro efficacy of an antibiotic releasing silicone ventricle catheter to prevent shunt infection. Biomaterials. 1994 Oct;15(12):996-1000. doi: 10.1016/0142-9612(94)90080-9.

ReferenceCitation: Zabramski JM, Whiting D, Darouiche RO, Horner TG, Olson J, Robertson C, Hamilton AJ. Efficacy of antimicrobial-impregnated external ventricular drain catheters: a prospective, randomized, controlled trial. J Neurosurg. 2003 Apr;98(4):725-30. doi: 10.3171/jns.2003.98.4.0725.

lead_sponsor: Codman & Shurtleff

location_country:
Norway
Hong Kong
Singapore
United Kingdom
United States
China
Canada
France

location_facility:
Prince of Wales Hospital
Singapore General Hospital
Tiantan Hospital
National Neuroscience Institute
Queen Mary Hospital
Xuan Wu Hospital

intervention_type: Device


title: A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

summary: To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

ReferenceCitation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repositories_concat: PubMed Central;www.lenus.ie

ReferenceCitation: Schreiber S, Reinisch W, Colombel JF, Sandborn WJ, Hommes DW, Robinson AM, Huang B, Lomax KG, Pollack PF. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis. 2013 Apr;7(3):213-21. doi: 10.1016/j.crohns.2012.05.015. Epub 2012 Jun 16.

publisher_dissemination: Oxford University Press

ReferenceCitation: Colombel JF, Schwartz DA, Sandborn WJ, Kamm MA, D'Haens G, Rutgeerts P, Enns R, Panaccione R, Schreiber S, Li J, Kent JD, Lomax KG, Pollack PF. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. 2009 Jul;58(7):940-8. doi: 10.1136/gut.2008.159251. Epub 2009 Feb 6.

lead_sponsor: Abbott

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Australia
Sweden
Netherlands
Belgium
United States
Spain
South Africa
Canada
France

location_facility:
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title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

summary: Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Finland
Poland
Hungary
United Kingdom
Romania
Sweden
Netherlands
Mexico
Belgium
Spain
South Africa
Croatia
Ukraine
Czech Republic
France


title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability and Efficacy of the CCR1 Antagonist ZK 811752, Given Orally in a Dose of 600 mg Three Times Daily, for the Treatment of Endometriosis Over 12 Weeks

summary: This study was designed as a proof-of-concept trial to evaluate safety, tolerability, and the efficacy of 1800 mg (ZK 811752 600 mg given orally three times daily) over 12 weeks for the treatment of endometriosis associated pelvic pain (EAPP) in comparison to placebo.

lead_sponsor: Bayer

location_country:
Finland
Denmark
Sweden
Netherlands
Spain
Czech Republic
France


title: Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency

summary: This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.

ReferenceCitation: Zacharin M, Szarras-Czapnik M, Racz K, Keller A, Tauber M, Conway G. Growth hormone (GH) treatment improves bone mineral density during transition of GH-deficient patients from adolescence to adulthood. European Society for Paediatric Endocrinology (ESPE) 2007; Country: Finland City: Helsinki

ReferenceCitation: Zacharin M, Keller A, Chanson P, Conway G on behalf of the 1369 GHD to GHDA. Efficacy of two years' growth hormone (GH) treatment on bone mineral density in young adults with childhood-onset GH deficiency. The Endocrine Society Annual Meeting (ENDO) 2007; Country: Canada City: Toronto

ReferenceCitation: Conway G, Scarras-Czapnik M, Racz K, Keller A, Chanson P, Kappelgaard A M, Zacharin M, Hyldstrup L. Direct X-ray radiogrammetry versus dual-energy X-ray absorptiometry: assessment of bone density in young adult with childhood-onset growth hormone deficiency treated with growth hormone. The Endocrine Society Annual Meeting (ENDO) 2008; Country: USA City: San Francisco

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Poland
Hungary
Norway
United Kingdom
Australia
Sweden
Switzerland
Austria
Belgium
Spain
France


title: A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

summary: The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

ReferenceCitation: Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11.

ReferenceCitation: O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):815-23.e1-3. doi: 10.1016/j.cgh.2012.12.029. Epub 2013 Jan 17.

ReferenceCitation: Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17.

publisher_dissemination: Informa

lead_sponsor: Shire

location_country:
Poland
United Kingdom
Denmark
Netherlands
Belgium
United States
Canada
France

location_facility: University of Pennsylvania - Penn Nursing

location_facility: Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP

location_facility: Academic Medical Center, Department of Endocrinology & Metabolism


title: An Extension to a Phase II Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha

summary: During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they had benefited from treatment with STI571 and there were no safety concerns.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
Switzerland
United States
France

location_facility: C/O V. Ward - Washington Univ. school of Medicine

location_facility: MD Anderson Cancer Center, University of Texas

location_facility: Northwestern Univ meical School/Robert H. Lurie Comprehensive Cancer Center

location_facility: H. Lee Moffet Cancer Center & Research Institute/Univ of South Florida

location_facility: Wayne State University/Kamanos Cancer Center


title: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

summary: This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate.

ReferenceCitation: Westhovens R, Kremer JM, Emery P, Russell AS, Alten R, Barre E, Dougados M. Long-term safety and efficacy of abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: a 7-year extended study. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):553-62. Epub 2014 Jul 8.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Ireland
United Kingdom
Argentina
Australia
Netherlands
Belgium
United States
South Africa
Canada
France


title: A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.

summary: Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension

ReferenceCitation: Simonneau G, Rubin LJ, Galie N, Barst RJ, Fleming TR, Frost A, Engel P, Kramer MR, Serdarevic-Pehar M, Layton GR, Sitbon O, Badesch DB; PACES Study Group. Long-term sildenafil added to intravenous epoprostenol in patients with pulmonary arterial hypertension. J Heart Lung Transplant. 2014 Jul;33(7):689-97. doi: 10.1016/j.healun.2014.02.019. Epub 2014 Feb 22.

location_country:
Italy
Israel
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
Czechia
Canada
France


title: A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.

summary: To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

ReferenceCitation: Pina-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017.

lead_sponsor: UCB Pharma

location_country:
France
Germany
Italy
Poland
India
Hungary
United Kingdom
Romania
Brazil
Mexico
Belgium
United States
South Africa
Canada
Russian Federation
Czech Republic


title: A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis

summary: Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Portugal
Hungary
Denmark
United States
India
Romania
Belgium
Peru
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Sweden

location_facility: Central de Especialidades Medicas (FIDEPAZ)

location_facility: Universidade Federal da Bahia - Hospital

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia

location_facility: Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)

location_facility: Hospital Nacional Guillermo Alemnara Irigoyen

location_facility: Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán

location_facility: Addenbrookes Hospital Department of Gastroenterology

location_facility: The Catholic University of Korea Kangnam St Mary's Hospital

location_facility: Octavian Fodor Clinical Emergency Hospital

location_facility: Institute of Gastronenterology & Hepatology

location_facility: Sree Gokulam Medical Centre & Research Foundation

location_facility: Heilig Hart ziekenhuis vzw Roeselare-Menen

location_facility: Hallyam University, Sacred Heart Hospital

location_facility: Hospital Italiano de Mendoza, FINAMED SA

location_facility: Hospital Universitario Germans Trias I Pujol

location_facility: Center for Digestive and Liver Diseases, Inc

location_facility: S.R. Kalla Memorial Gastro & General Hospital

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Gastroenterologische Praxis Prof. Hackelsberger


title: A Multicenter Study to Describe the Immunogenic Epitope(s) of Factor VIII in Previously Treated Patients With Congenital Hemophilia A Who Develop De Novo Factor VIII Inhibitors While Receiving Factor VIII Infusion Therapy.

summary: This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of current or prior FVIII inhibitor will be included for comparison. The objective of this study is to describe the patterns of antibodies and associated epitopes in the study population.

status: Withdrawn

primary_purpose: Diagnostic

sponsor_collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Spain
France

intervention_type: Procedure


title: PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

acronym: PEARL

summary: The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.

ReferenceCitation: Ensrud K, LaCroix A, Thompson JR, Thompson DD, Eastell R, Reid DM, Vukicevic S, Cauley J, Barrett-Connor E, Armstrong R, Welty F, Cummings S. Lasofoxifene and cardiovascular events in postmenopausal women with osteoporosis: Five-year results from the Postmenopausal Evaluation and Risk Reduction with Lasofoxifene (PEARL) trial. Circulation. 2010 Oct 26;122(17):1716-24. doi: 10.1161/CIRCULATIONAHA.109.924571. Epub 2010 Oct 11.

ReferenceCitation: Cummings SR, Ensrud K, Delmas PD, LaCroix AZ, Vukicevic S, Reid DM, Goldstein S, Sriram U, Lee A, Thompson J, Armstrong RA, Thompson DD, Powles T, Zanchetta J, Kendler D, Neven P, Eastell R; PEARL Study Investigators. Lasofoxifene in postmenopausal women with osteoporosis. N Engl J Med. 2010 Feb 25;362(8):686-96. doi: 10.1056/NEJMoa0808692. Erratum In: N Engl J Med. 2011 Jan 20;364(3):290. Kucu kdeveci A [corrected to Kucukdeveci, A].

lead_sponsor: Ligand Pharmaceuticals

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Costa Rica
Japan
Turkey
Croatia
Canada
France
Lithuania
Hungary
Hong Kong
Denmark
United States
India
Romania
Belgium
Estonia
Egypt
Italy
Norway
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Russian Federation
Sweden


title: Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

summary: This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
United Kingdom
United States
Canada
France

location_facility: St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis

location_facility: Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department

location_facility: Arthritis & Osteoporosis Center of Maryland

location_facility: Southampton General Hospital, MRC Environmental Epidemiology Unit

location_facility: Centre Hospitalier Lyon-Sud, Service de Rhumatologie

location_facility: Midwest Orthopedics at Rush University Medical Center

location_facility: Orthopedic Center for Joint Replacement and Sports

location_facility: Northwestern Center for Clinical Research

location_facility: CHU Hôpital Trousseau Service de Rhumatologie

location_facility: Maidstone General Hospital & Tunbridge Wells NHS Trust

location_facility: Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research


title: Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia

summary:
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

lead_sponsor: Pfizer

location_country:
Norway
Denmark
Australia
Sweden
United States
Iceland
South Africa
Canada
France


title: Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507

summary: The purpose of this study is to evaluate the long-term safety and profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507.

lead_sponsor: MedImmune LLC

location_country:
Germany
Netherlands
Belgium
United States
Canada
France

location_facility: Academisch Medisch Centrum/Universiteit van Amsterdam (AMC/UvA)

location_facility: Klinikum de Johann - Wolfgang Goethe Universitate Frankfurt

location_facility: Capital District Health Authority, QE II Health Sciences Center

location_facility: Hospital Saint-Louis Service de Dermatologie 1

location_facility: Washington University, Dermatology Clinical Trials Unit

location_facility: Hospital Haut Leveque CHU Sud -Service de Dermatologie

location_facility: Atlanta Dermatology, Vein & Research Center, LLC

intervention_type: Other


title: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares

summary: The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

ReferenceCitation: Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.

ReferenceCitation: Bandyopadhyay S, Connolly SE, Jabado O, Ye J, Kelly S, Maldonado MA, Westhovens R, Nash P, Merrill JT, Townsend RM. Identification of biomarkers of response to abatacept in patients with SLE using deconvolution of whole blood transcriptomic data from a phase IIb clinical trial. Lupus Sci Med. 2017 Jul 28;4(1):e000206. doi: 10.1136/lupus-2017-000206. eCollection 2017.

publisher_dissemination: British Medical Journal

ReferenceCitation: Merrill JT, Burgos-Vargas R, Westhovens R, Chalmers A, D'Cruz D, Wallace DJ, Bae SC, Sigal L, Becker JC, Kelly S, Raghupathi K, Li T, Peng Y, Kinaszczuk M, Nash P. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Oct;62(10):3077-87. doi: 10.1002/art.27601.

location_country:
Germany
Italy
United Kingdom
Australia
Brazil
Austria
Belgium
Mexico
United States
Korea, Republic of
South Africa
Taiwan
Canada
Puerto Rico
France

location_facility: Kentuckiana Center For Better Bone And Joint Health


title: A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures

summary: The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).

ReferenceCitation: Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, Wang S, Weber T, Kurland CL, Yuen E, Eerdekens M, Venkatraman L, Nye JS, Ford L. Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology. 2010 Mar 2;74(9):714-20. doi: 10.1212/WNL.0b013e3181d1cd4c. Epub 2010 Jan 20.

ReferenceCitation: Ness S, Todd MJ, Wang S, Eerdekens M, Nye JS, Ford L. Adaptive behavior outcomes in infants treated with adjunctive topiramate. Pediatr Neurol. 2012 Jun;46(6):350-8. doi: 10.1016/j.pediatrneurol.2012.02.028.

ReferenceCitation: Puri V, Ness S, Sattaluri SJ, Wang S, Todd M, Yuen E, Eerdekens M, Nye JS, Manitpisitkul P, Shalayda K, Ford L. Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures. J Child Neurol. 2011 Oct;26(10):1271-83. doi: 10.1177/0883073811406982. Epub 2011 Jun 14.

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Finland
Poland
New Zealand
Argentina
Australia
Thailand
Chile
Canada
France
Hungary
United States
Ukraine
India
Belgium
Norway
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


title: An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer

summary: The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

ReferenceCitation: Jones RL, Herzog TJ, Patel SR, von Mehren M, Schuetze SM, Van Tine BA, Coleman RL, Knoblauch R, Triantos S, Hu P, Shalaby W, McGowan T, Monk BJ, Demetri GD. Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer. Cancer Med. 2021 Jun;10(11):3565-3574. doi: 10.1002/cam4.3903. Epub 2021 May 7.

repository_institution: University of Michigan - Deep Blue

repository_institution: Washington University School of Medicine - Digital Commons@Becker

ReferenceCitation: Krasner CN, Poveda A, Herzog TJ, Vermorken JB, Kaye SB, Nieto A, Claret PL, Park YC, Parekh T, Monk BJ. Patient-reported outcomes in relapsed ovarian cancer: results from a randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone. Gynecol Oncol. 2012 Oct;127(1):161-7. doi: 10.1016/j.ygyno.2012.06.034. Epub 2012 Jul 2.

ReferenceCitation: Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Park YC, Parekh TV, Poveda AM. Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer: overall survival analysis. Eur J Cancer. 2012 Oct;48(15):2361-8. doi: 10.1016/j.ejca.2012.04.001. Epub 2012 Apr 26.

sponsor_collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Canada
France
Hong Kong
United States
Belgium
China
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden


title: A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Combination With Paclitaxel as Neoadjuvant Therapy in Patients With Newly Diagnosed Inflammatory Breast Cancer

summary: This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.

ReferenceCitation: Boussen H, Cristofanilli M, Zaks T, DeSilvio M, Salazar V, Spector N. Phase II study to evaluate the efficacy and safety of neoadjuvant lapatinib plus paclitaxel in patients with inflammatory breast cancer. J Clin Oncol. 2010 Jul 10;28(20):3248-55. doi: 10.1200/JCO.2009.21.8594. Epub 2010 Jun 7.

lead_sponsor: GlaxoSmithKline

location_country:
France
New Zealand
United Kingdom
Australia
Tunisia
United States
Spain
Canada
Israel


title: Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

summary:
This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

ReferenceCitation: Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13. doi: 10.1111/j.1538-7836.2007.02663.x.

location_country:
Poland
Russian Federation
Argentina
Romania
Brazil
United States
Spain
South Africa
Turkey
Bulgaria
Philippines
France


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

summary: A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

lead_sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Thailand
Pakistan
Czechia
Canada
France
Portugal
Hungary
Hong Kong
United States
India
Peru
Philippines
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation


title: A Randomized, Two-Cohort Phase II Study of Two Doses of BMS-275183 Given on a Weekly Schedule in Patients With Pre-Treated Non-Small Cell Lung Cancer

summary: The purpose of this clinical research study is to learn if BMS-275183 can shrink or slow the growth of the cancer in subjects with non-small cell lung cancer (NSCLC). The safety of this treatment will also be studied.

location_country:
Italy
United Kingdom
Netherlands
Belgium
United States
Spain
France

location_facility:
Local Insitution
Local Institution


title: A Randomized, Placebo-controlled, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

summary: This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
Guatemala
Hungary
Argentina
United Kingdom
Australia
Switzerland
Mexico
Belgium
United States
Panama
Chile
Canada
Puerto Rico
Russian Federation
France


title: A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate

summary: The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.

status: Approved for marketing

study_type: Expanded Access

ReferenceCitation: Reichardt P, Kang YK, Rutkowski P, Schuette J, Rosen LS, Seddon B, Yalcin S, Gelderblom H, Williams CC Jr, Fumagalli E, Biasco G, Hurwitz HI, Kaiser PE, Fly K, Matczak E, Chen L, Lechuga MJ, Demetri GD. Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib. Cancer. 2015 May 1;121(9):1405-13. doi: 10.1002/cncr.29220. Epub 2015 Jan 13. Erratum In: Cancer. 2019 Mar 1;125(5):821.

oa_host_type: repository

version: acceptedVersion

unpaywall_oa_status: green

ReferenceCitation: Dudeck O, Zeile M, Reichardt P, Pink D. Comparison of RECIST and Choi criteria for computed tomographic response evaluation in patients with advanced gastrointestinal stromal tumor treated with sunitinib. Ann Oncol. 2011 Aug;22(8):1828-33. doi: 10.1093/annonc/mdq696. Epub 2011 Feb 2.

location_country:
Finland
Germany
Poland
Argentina
Australia
Thailand
Turkey
Chile
Canada
France
Czech Republic
Colombia
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
India
Belgium
Italy
Norway
Singapore
United Kingdom
Venezuela
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel


title: Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

summary: The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.

ReferenceCitation: Sheetz MJ, Aiello LP, Davis MD, Danis R, Bek T, Cunha-Vaz J, Shahri N, Berg PH; MBDL and MBCU Study Groups. The effect of the oral PKC beta inhibitor ruboxistaurin on vision loss in two phase 3 studies. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1750-7. doi: 10.1167/iovs.12-11055.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

publisher_dissemination: Association for Research in Vision and Ophthalmology (ARVO)

lead_sponsor: Chromaderm, Inc.

location_country:
Germany
Italy
Poland
India
Portugal
United Kingdom
Denmark
Australia
Brazil
Netherlands
Mexico
United States
Spain
Taiwan
Canada
Russian Federation
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.