title: A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

lead_sponsor: Eisai Inc.

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.

ReferenceCitation: French JA, Gil-Nagel A, Malerba S, Kramer L, Kumar D, Bagiella E. Time to prerandomization monthly seizure count in perampanel trials: A novel epilepsy endpoint. Neurology. 2015 May 19;84(20):2014-20. doi: 10.1212/WNL.0000000000001585. Epub 2015 Apr 15.

ReferenceCitation: Rosenfeld W, Conry J, Lagae L, Rozentals G, Yang H, Fain R, Williams B, Kumar D, Zhu J, Laurenza A. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015 Jul;19(4):435-45. doi: 10.1016/j.ejpn.2015.02.008. Epub 2015 Mar 5.

ReferenceCitation: Steinhoff BJ, Ben-Menachem E, Ryvlin P, Shorvon S, Kramer L, Satlin A, Squillacote D, Yang H, Zhu J, Laurenza A. Efficacy and safety of adjunctive perampanel for the treatment of refractory partial seizures: a pooled analysis of three phase III studies. Epilepsia. 2013 Aug;54(8):1481-9. doi: 10.1111/epi.12212. Epub 2013 May 10.

ReferenceCitation: French JA, Krauss GL, Steinhoff BJ, Squillacote D, Yang H, Kumar D, Laurenza A. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: results of randomized global phase III study 305. Epilepsia. 2013 Jan;54(1):117-25. doi: 10.1111/j.1528-1167.2012.03638.x. Epub 2012 Aug 20.

location_country:
United Kingdom
Italy
Austria
Netherlands
Russian Federation
Finland
Sweden
United States
France
India
Israel
Belgium
South Africa
Germany

location_facility: Neurological Research Center at Hattiesburg Clinic

location_facility: North Alabama Neuroscience Research Associates

location_facility: Neurology Associates of Northern Colorado

location_facility: The Comprehensive Care Center for Children And Adults

location_facility: Dean Foundation for Health, Research and Education, Inc.

location_facility: Saint Luke's Comprehensive Epilepsy Center

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.


status: Completed

primary_purpose: Treatment

intervention_type: Drug

title: A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-related Symptoms Are Inadequately Controlled by Somatostatin Analogues.

study_completion_date_type: Actual

lead_sponsor: Novartis Pharmaceuticals

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_type: Interventional

enrollment_type: Actual

location_country:
Poland
Brazil
Spain
Italy
Austria
United Kingdom
Argentina
Canada
Sweden
United States
France
Israel
Singapore
Belgium
Norway
Germany

location_facility: University of Arizona / Arizona Cancer Center

location_facility: Loma Linda University Dept. of Loma Linda CancerCent

location_facility: Mount Sinai School of Medicine Study Coordinator

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network

location_facility: Duke University Medical Center Dept. of Duke Cancer Center(2)

location_facility: MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (9)

location_facility: Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service

location_facility: Cedars Sinai Medical Center Cedars Sinai 4

location_facility: H. Lee Moffitt Cancer Center/University of South Florida Dept of H. Lee Moffit

summary: The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.

acronym: FINDER

summary: The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

lead_sponsor: Bayer

location_country:
Denmark
Spain
United Kingdom
Finland
France
Belgium
Germany


title: A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

summary: This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

ReferenceType: result

ReferenceCitation: Nauck MA, Del Prato S, Meier JJ, Durán-García S, Rohwedder K, Elze M, Parikh SJ. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011 Sep;34(9):2015-22. doi: 10.2337/dc11-0606. Epub 2011 Aug 4.

ReferenceType: derived

ReferenceCitation: Nauck M, del Prato S, Meier JJ, Durán-García S, Rohwedder K, Elze M, Parikh SJ. [Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S6-15. doi: 10.1055/s-0032-1305283. Epub 2013 Mar 25. German.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
Netherlands
Argentina
Sweden
France
South Africa
Mexico
Germany


acronym: Extension trial to Trial 25643: Oral Cladribine in MS

title: A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY)

lead_sponsor: EMD Serono Research & Development Institute, Inc.

study_start_date_type: Actual

ReferenceCitation: Stefano N, Sormani MP, Giovannoni G, Rammohan K, Leist TP, Coyle PK, Dangond F, Alexandri N, Galazka A. Relapses in people with multiple sclerosis treated with cladribine tablets followed for up to 5 years: a plain language summary. Neurodegener Dis Manag. 2022 Dec;12(6):303-310. doi: 10.2217/nmt-2022-0019. Epub 2022 Aug 26. Review.

ReferenceCitation: Giovannoni G, Comi G, Rammohan K, Rieckmann P, Dangond F, Jack D, Vermersch P. Disease stability over five years in people with multiple sclerosis treated with cladribine tablets: a plain language summary. Neurodegener Dis Manag. 2022 Dec;12(6):295-301. doi: 10.2217/nmt-2022-0018. Epub 2022 Aug 26. Review.

ReferenceCitation: Giovannoni G, Coyle PK, Vermersch P, Walker B, Aldridge J, Nolting A, Galazka A, Lemieux C, Leist TP. Integrated Lymphopenia Analysis in Younger and Older Patients With Multiple Sclerosis Treated With Cladribine Tablets. Front Immunol. 2021 Dec 24;12:763433. doi: 10.3389/fimmu.2021.763433. eCollection 2021.

ReferenceCitation: Giovannoni G, Comi G, Rammohan K, Rieckmann P, Dangond F, Keller B, Jack D, Vermersch P. Long-Term Disease Stability Assessed by the Expanded Disability Status Scale in Patients Treated with Cladribine Tablets 3.5 mg/kg for Relapsing Multiple Sclerosis: An Exploratory Post Hoc Analysis of the CLARITY and CLARITY Extension Studies. Adv Ther. 2021 Sep;38(9):4975-4985. doi: 10.1007/s12325-021-01865-w. Epub 2021 Aug 9.

ReferenceCitation: De Stefano N, Sormani MP, Giovannoni G, Rammohan K, Leist T, Coyle PK, Dangond F, Keller B, Alexandri N, Galazka A. Analysis of frequency and severity of relapses in multiple sclerosis patients treated with cladribine tablets or placebo: The CLARITY and CLARITY Extension studies. Mult Scler. 2022 Jan;28(1):111-120. doi: 10.1177/13524585211010294. Epub 2021 May 10.

ReferenceCitation: Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.

ReferenceCitation: Comi G, Cook S, Rammohan K, Soelberg Sorensen P, Vermersch P, Adeniji AK, Dangond F, Giovannoni G. Long-term effects of cladribine tablets on MRI activity outcomes in patients with relapsing-remitting multiple sclerosis: the CLARITY Extension study. Ther Adv Neurol Disord. 2018 Jan 23;11:1756285617753365. doi: 10.1177/1756285617753365. eCollection 2018.

location_country:
Croatia
Serbia
Saudi Arabia
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Tunisia
Turkey
Brazil
Lebanon
Canada
Switzerland
Germany
Bulgaria
Denmark
Greece
Latvia
Estonia
Finland
France
Netherlands
Morocco

location_facility:
Reseach Site
Research Site

summary: The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.


acronym: POTENT I

title: Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial - POTENT I

ReferenceCitation: Debruyne FM, Gittelman M, Sperling H, Börner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30.

ReferenceCitation: Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.

ReferenceCitation: Heinig R, Weimann B, Dietrich H, Böttcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.

ReferenceCitation: Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.

location_country:
Belgium
Spain
Netherlands
France
South Africa
Germany

summary: This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.


acronym: RAD

title: A 24 Month, Multicenter, Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

ReferenceCitation: Charlton M, Rinella M, Patel D, McCague K, Heimbach J, Watt K. Everolimus Is Associated With Less Weight Gain Than Tacrolimus 2 Years After Liver Transplantation: Results of a Randomized Multicenter Study. Transplantation. 2017 Dec;101(12):2873-2882. doi: 10.1097/TP.0000000000001913.

ReferenceCitation: Fischer L, Saliba F, Kaiser GM, De Carlis L, Metselaar HJ, De Simone P, Duvoux C, Nevens F, Fung JJ, Dong G, Rauer B, Junge G; H2304 Study Group. Three-year Outcomes in De Novo Liver Transplant Patients Receiving Everolimus With Reduced Tacrolimus: Follow-Up Results From a Randomized, Multicenter Study. Transplantation. 2015 Jul;99(7):1455-62. doi: 10.1097/TP.0000000000000555.

ReferenceCitation: Saliba F, De Simone P, Nevens F, De Carlis L, Metselaar HJ, Beckebaum S, Jonas S, Sudan D, Fischer L, Duvoux C, Chavin KD, Koneru B, Huang MA, Chapman WC, Foltys D, Dong G, Lopez PM, Fung J, Junge G; H2304 Study Group. Renal function at two years in liver transplant patients receiving everolimus: results of a randomized, multicenter study. Am J Transplant. 2013 Jul;13(7):1734-45. doi: 10.1111/ajt.12280. Epub 2013 May 28.

location_country:
Brazil
Spain
Colombia
Ireland
Australia
Italy
Argentina
Canada
Czech Republic
Netherlands
Russian Federation
Hungary
Sweden
United States
France
Israel
United Kingdom
Belgium
Germany

summary: This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.


acronym: RE-DEEM

title: RandomizEd Dabigatran Etexilate Dose Finding Study in Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors for Cardiovascular Complications Also Receiving Aspirin and Clopidogrel: Multi-centre, Prospective, Placebo Controlled, Cohort Dose Escalation Study (RE-DEEM)

lead_sponsor: Boehringer Ingelheim

type: Other Identifier

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Poland
Russian Federation
India
Norway
Sweden
Canada
Hungary
Germany
Bulgaria
Denmark
Ireland
Georgia
Finland
Czech Republic
Korea, Republic of
France
Netherlands

location_facility: 1160.67.59009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49015 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.44003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11017 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303C Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49019 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3301A Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11016 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.53002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59012 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11012 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.53001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82012 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.10002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.44001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.44002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3305B Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303D Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3305A Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11014 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303A Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303B Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11018 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11020 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82013 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49017 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49008 Boehringer Ingelheim Investigational Site

summary: The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.


title: A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer

acronym: ENTHUSE M1C

summary:
Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.

All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.

Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.

ReferenceCitation: Fizazi K, Higano CS, Nelson JB, Gleave M, Miller K, Morris T, Nathan FE, McIntosh S, Pemberton K, Moul JW. Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2013 May 10;31(14):1740-7. doi: 10.1200/JCO.2012.46.4149. Epub 2013 Apr 8. Erratum in: J Clin Oncol. 2014 Oct 20;32(30):3461. Fizazi, Karim S [Corrected to Fizazi, Karim].

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Peru
Romania
South Africa
Poland
Portugal
Russian Federation
Australia
Argentina
India
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Taiwan
Finland
Czech Republic
Korea, Republic of
France
Netherlands


primary_purpose: Prevention

title: Efficacy and Safety of Alefacept in Combination With Tacrolimus, Mycophenolate Mofetil and Steroids in de Novo Kidney Transplantation - a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Czech Republic
Sweden
Hungary
France
Belgium
Germany

summary: The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.


title: A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

ReferenceCitation: Bronstein MD, Fleseriu M, Neggers S, Colao A, Sheppard M, Gu F, Shen CC, Gadelha M, Farrall AJ, Hermosillo Reséndiz K, Ruffin M, Chen Y, Freda P; Pasireotide C2305 Study Group. Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study. BMC Endocr Disord. 2016 Apr 2;16:16. doi: 10.1186/s12902-016-0096-8.

ReferenceCitation: Shanik MH, Cao PD, Ludlam WH. HISTORICAL RESPONSE RATES OF SOMATOSTATIN ANALOGUES IN THE TREATMENT OF ACROMEGALY: A SYSTEMATIC REVIEW. Endocr Pract. 2016 Mar;22(3):350-6. doi: 10.4158/EP15913.RA. Epub 2015 Oct 5. Review.

ReferenceCitation: Sheppard M, Bronstein MD, Freda P, Serri O, De Marinis L, Naves L, Rozhinskaya L, Hermosillo Reséndiz K, Ruffin M, Chen Y, Colao A. Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study. Pituitary. 2015 Jun;18(3):385-94. doi: 10.1007/s11102-014-0585-6. Erratum in: Pituitary. 2015 Jun;18(3):395-6.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France
Colombia
Netherlands

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

location_facility: Cedars Sinai Medical Center The Pituitary Center

location_facility: Columbia University Medical Center- New York Presbyterian Dept. of CU Collegeof Phys&Sur

location_facility: Northport VA Medical Center CSOM230C2305

location_facility: Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv.

location_facility: Oregon Health & Sciences University DeptofOregonHealth&Sciences(3)

location_facility: University of Texas/MD Anderson Cancer Center Regulatory -12

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

location_facility: University of California at Los Angeles Division of Endocrinology

location_facility: University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes

location_facility: University of Texas Southwestern Medical Center Danziger Research Bldg.

summary:
The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.

The objective of this study was to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

Following one year of treatment patients could proceed into the study extension.

Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.


title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder

lead_sponsor: H. Lundbeck A/S

ReferenceCitation: Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Théroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5.

ReferenceCitation: Belzeaux R, Fiori LM, Lopez JP, Boucekine M, Boyer L, Blier P, Farzan F, Frey BN, Giacobbe P, Lam RW, Leri F, MacQueen GM, Milev R, Müller DJ, Parikh SV, Rotzinger S, Soares CN, Uher R, Foster JA, Kennedy SH, Turecki G. Predicting Worsening Suicidal Ideation With Clinical Features and Peripheral Expression of Messenger RNA and MicroRNA During Antidepressant Treatment. J Clin Psychiatry. 2019 May 7;80(3). pii: 18m12556. doi: 10.4088/JCP.18m12556.

location_country:
Serbia
Austria
Australia
Russian Federation
Canada
Czech Republic
Finland
Lithuania
Sweden
Ukraine
Philippines
Korea, Republic of
France
India
Belgium
Norway
Malaysia

summary: The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo


title: A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 on Mean 24-hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

lead_sponsor: Novartis

location_country: Spain Italy Australia Canada France Turkey Belgium Germany

location_facility:
Novartis Investigator site
Novartis investigator site
Novartis Investigator Site


title: A Phase III, Randomized, Double-blind Trial of TMC278 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-naive HIV-1 Infected Subjects.

summary: The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.

ReferenceCitation: Rimsky L, Van Eygen V, Hoogstoel A, Stevens M, Boven K, Picchio G, Vingerhoets J. 96-Week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antivir Ther. 2013;18(8):967-77. doi: 10.3851/IMP2636. Epub 2013 May 28.

ReferenceCitation: Nelson M, Amaya G, Clumeck N, Arns da Cunha C, Jayaweera D, Junod P, Li T, Tebas P, Stevens M, Buelens A, Vanveggel S, Boven K; ECHO and THRIVE Study Groups. Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials. J Antimicrob Chemother. 2012 Aug;67(8):2020-8. doi: 10.1093/jac/dks130. Epub 2012 Apr 24.

ReferenceCitation: Molina JM, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, Supparatpinyo K, Walmsley S, Crauwels H, Rimsky LT, Vanveggel S, Boven K; ECHO study group. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011 Jul 16;378(9787):238-46. doi: 10.1016/S0140-6736(11)60936-7.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Denmark
Taiwan
Brazil
Portugal
Romania
Spain
Austria
Australia
Russian Federation
Argentina
Canada
Thailand
United Kingdom
Sweden
Puerto Rico
United States
France
South Africa
Mexico
Netherlands


acronym: ODIN

title: A Randomized, Open-label Trial to Compare the Efficacy, Safety and Tolerability of DRV/Rtv (800mg/100mg) q.d Versus DRV/Rtv (600mg/100mg) b.i.d in Early Treatment-experienced HIV-1 Infected Subjects

ReferenceCitation: Lathouwers E, De La Rosa G, Van de Casteele T, Baeten B, Tomaka F, De Meyer S, Picchio G. Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Antivir Ther. 2013;18(3):289-300. doi: 10.3851/IMP2569. Epub 2013 Apr 4.

location_country:
Taiwan
Brazil
Romania
Spain
United Kingdom
Austria
Australia
Argentina
Thailand
Guatemala
Hungary
Puerto Rico
United States
Chile
France
Malaysia
Panama
South Africa
Germany

summary: The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).


title: A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-naïve Patients With Chronic he

summary: This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Nelson DR, Zeuzem S, Andreone P, Ferenci P, Herring R, Jensen DM, Marcellin P, Pockros PJ, Rodríguez-Torres M, Rossaro L, Rustgi VK, Sepe T, Sulkowski M, Thomason IR, Yoshida EM, Chan A, Hill G. Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients. Ann Hepatol. 2012 Jan-Feb;11(1):15-31.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
Austria
Australia
Canada
Puerto Rico
United States
France
Germany


title: A Prospective, Randomized, Open-labelled, Multi-centre Trial Comparing the Safety and Efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to That of Prezista® (Darunavir, DRV/r) in Three-class (NRTI, NNRTI, and PI) Treatment-experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients

summary: The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.

status: Terminated

ReferenceCitation: Elgadi MM, Piliero PJ. Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial. Drugs R D. 2011 Dec 1;11(4):295-302. doi: 10.2165/11596340-000000000-00000.

location_country:
Portugal
Spain
Greece
Italy
Canada
Thailand
Puerto Rico
United States
France
Belgium
Bahamas
Germany

location_facility: 1182.71.3403 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3312A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.4902 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1118 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1101 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3003 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1108 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1109 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3001 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1116 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3912 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3405 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1124 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3504 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1016 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1115 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3908 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.4903 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3503 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3206 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3907 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3402 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1006 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6601 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6605 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3301A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1010 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3308A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3401 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1001 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3202 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3205 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.4907 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3919 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3407 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3002 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6602 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3306A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3203 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3310A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6604 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3916 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3303A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1129 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3408 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1126 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6603 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1104 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3502 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1002 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6606 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3901 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1003 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3305A Boehringer Ingelheim Investigational Site

status_simplified: Unknown


title: A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

summary: A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155

design_allocation: Non-Randomized

location_country:
United States
Spain
Canada
France


title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies

summary: This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.

ReferenceCitation: Lal P, Su Z, Holweg CT, Silverman GJ, Schwartzman S, Kelman A, Read S, Spaniolo G, Monroe JG, Behrens TW, Townsend MJ. Inflammation and autoantibody markers identify rheumatoid arthritis patients with enhanced clinical benefit following rituximab treatment. Arthritis Rheum. 2011 Dec;63(12):3681-91. doi: 10.1002/art.30596.

ReferenceCitation: Keystone E, Burmester GR, Furie R, Loveless JE, Emery P, Kremer J, Tak PP, Broder MS, Yu E, Cravets M, Magrini F, Jost F. Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis Rheum. 2008 Jun 15;59(6):785-93. doi: 10.1002/art.23715.

location_country:
United Kingdom
Ireland
Italy
Netherlands
Canada
United States
France
Israel
Belgium
Norway
Germany

intervention_type: Other


title: Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy (Bronchodilation) and Safety of 4 Weeks of Treatment of Orally Inhaled BI 1744 CL (4 Doses) Delivered by the Respimat® Inhaler in Patients With Asthma

summary: The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).

ReferenceCitation: O'Byrne PM, D'Urzo T, Beck E, Fležar M, Gahlemann M, Hart L, Blahova Z, Toorawa R, Beeh KM. Dose-finding evaluation of once-daily treatment with olodaterol, a novel long-acting β2-agonist, in patients with asthma: results of a parallel-group study and a crossover study. Respir Res. 2015 Aug 18;16:97. doi: 10.1186/s12931-015-0249-8.

location_country:
Germany
United States
Canada
France

location_facility: 1222.6.062 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.013 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.006 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.034 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.073 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.005 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.003 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.066 Allergy & Asthma Medical Group and Rsrch Ctr, APC

location_facility: 1222.6.009 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.011 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.007 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3303A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.067 Northeast Medical Research Associates, Inc

location_facility: 1222.6.037 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3308A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3304A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.012 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.017 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.064 Arthur F. Gelb Medical Corporation, Lakewood

location_facility: 1222.6.3302A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.015 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3301A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.036 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.069 Allergy Associates Medical Group

location_facility: 1222.6.038 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.072 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.068 National Jewish Medical Center

location_facility: 1222.6.004 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3306A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.032 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.008 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3305A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.016 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.031 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.002 Boehringer Ingelheim Investigational Site


title: A Multicentre, Randomised, Double-Blind, Tacrolimus Dual Therapy-Controlled, Parallel Group, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of FK778 in Liver Transplant Patients Receiving Standard Tacrolimus (FK506) and Steroids Therapy

summary: A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Czech Republic
Switzerland
Hungary
France
Belgium
Germany


title: A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

acronym: CONFIRM

summary:
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

ReferenceCitation: Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020. Erratum in: Ther Adv Neurol Disord. 2020 Oct 21;13:1756286420968357.

ReferenceCitation: Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.

ReferenceCitation: Fox RJ, Gold R, Phillips JT, Okwuokenye M, Zhang A, Marantz JL. Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM. Neurol Ther. 2017 Dec;6(2):175-187. doi: 10.1007/s40120-017-0077-5. Epub 2017 Aug 2.

ReferenceCitation: Fernández Ó, Giovannoni G, Fox RJ, Gold R, Phillips JT, Potts J, Okwuokenye M, Marantz JL. Efficacy and Safety of Delayed-release Dimethyl Fumarate for Relapsing-remitting Multiple Sclerosis in Prior Interferon Users: An Integrated Analysis of DEFINE and CONFIRM. Clin Ther. 2017 Aug;39(8):1671-1679. doi: 10.1016/j.clinthera.2017.06.012. Epub 2017 Jul 25.

ReferenceCitation: Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.

ReferenceCitation: Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.

ReferenceCitation: Giovannoni G, Gold R, Fox RJ, Kappos L, Kita M, Yang M, Sarda SP, Zhang R, Viglietta V, Havrdova E. Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies. Clin Ther. 2015 Nov 1;37(11):2543-51. doi: 10.1016/j.clinthera.2015.09.011. Epub 2015 Oct 31.

ReferenceCitation: Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevin RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Curr Med Res Opin. 2014 Feb;30(2):251-62. doi: 10.1185/03007995.2013.849236. Epub 2013 Oct 22. Review.

ReferenceCitation: Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. Erratum in: N Engl J Med. 2012 Oct 25;367(17):1673.

lead_sponsor: Biogen

location_country: Macedonia, The Former Yugoslav Republic of


title: An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.

summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Canada
Czech Republic
Hungary
United States
France
Israel
Belgium
Germany


title: A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer

summary: The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

ReferenceCitation: Crown JP, Diéras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G, Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol. 2013 Aug 10;31(23):2870-8. doi: 10.1200/JCO.2012.43.3391. Epub 2013 Jul 15.

lead_sponsor: Pfizer

location_country:
Denmark
Poland
Romania
Spain
Greece
Austria
Ireland
Italy
Canada
Czech Republic
Netherlands
Russian Federation
United Kingdom
United States
France
Belgium
Norway
Germany


title: A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors

summary:
This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug.

The study was designed to detect a 50% improvement in median PFS[Progression Free Survival] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred.

Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC [Data Monitoring Committee]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.

ReferenceCitation: Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan;16(1):27-35. doi: 10.1007/s11523-020-00784-0. Epub 2021 Jan 7.

ReferenceCitation: Lamarca A, Barriuso J, Kulke M, Borbath I, Lenz HJ, Raoul JL, Meropol NJ, Lombard-Bohas C, Posey J, Faivre S, Raymond E, Valle JW. Determination of an optimal response cut-off able to predict progression-free survival in patients with well-differentiated advanced pancreatic neuroendocrine tumours treated with sunitinib: an alternative to the current RECIST-defined response. Br J Cancer. 2018 Jan;118(2):181-188. doi: 10.1038/bjc.2017.402. Epub 2017 Nov 21.

ReferenceCitation: Vinik A, Bottomley A, Korytowsky B, Bang YJ, Raoul JL, Valle JW, Metrakos P, Hörsch D, Mundayat R, Reisman A, Wang Z, Chao RC, Raymond E. Patient-Reported Outcomes and Quality of Life with Sunitinib Versus Placebo for Pancreatic Neuroendocrine Tumors: Results From an International Phase III Trial. Target Oncol. 2016 Dec;11(6):815-824.

ReferenceCitation: Faivre S, Niccoli P, Castellano D, Valle JW, Hammel P, Raoul JL, Vinik A, Van Cutsem E, Bang YJ, Lee SH, Borbath I, Lombard-Bohas C, Metrakos P, Smith D, Chen JS, Ruszniewski P, Seitz JF, Patyna S, Lu DR, Ishak KJ, Raymond E. Sunitinib in pancreatic neuroendocrine tumors: updated progression-free survival and final overall survival from a phase III randomized study. Ann Oncol. 2017 Feb 1;28(2):339-343. doi: 10.1093/annonc/mdw561.

ReferenceCitation: Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Hörsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. doi: 10.1056/NEJMoa1003825. Erratum in: N Engl J Med. 2011 Mar 17;364(11):1082.

location_country:
Taiwan
Spain
Italy
United Kingdom
Australia
Canada
Korea, Republic of
United States
France
Belgium
Germany


title: The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.

summary: To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

ReferenceCitation: Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foà R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. Erratum in: N Engl J Med. 2009 Jul 30;361(5):544.

ReferenceCitation: San-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):38-43. doi: 10.3816/CLML.2010.n.120.

ReferenceCitation: Zangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9.

ReferenceCitation: Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17.

lead_sponsor: Celgene

location_country:
Poland
Spain
Greece
Austria
Australia
Ireland
Italy
United Kingdom
Switzerland
Ukraine
Sweden
France
Israel
Belgium
Germany

location_facility: Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Institute of Hematology and Transfusiology of the UAMS Department of blood diseases

location_facility: Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department

location_facility: Dnepropetrovsk City Clinical Hospital #4

location_facility: Sahlgrenska University Hospital Department of Hematology and Coagulation

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin

location_facility: Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V

location_facility: Hospital Universtario Marques de Valdecilla

location_facility: Policlinico Universitario a Gesttione diretta di Udine

location_facility: Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

location_facility: Kiev Bone Marrow Transplantation Center Bone Marrow Department

location_facility: University Hospital of Salzburg St Johanns Spital

location_facility: Haematology Dept, 4th Floor Thomas Guy House

location_facility: University Hospital GalwayHaematology Department

location_facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

location_facility: Institute of Internal Diseases University of Medicine

location_facility: Universitatsklinik Muenster Medizinische Klinik A

location_facility: Hope Directorate Haematology Oncology Service St. James Hospital

location_facility: Belfast City HospitalHaematology Department

location_facility: Institute of Haematology and Blood Transfusion


title: A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

summary: The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

ReferenceCitation: Bennett RM, Benson B, Choy EH, Hackshaw KV, Alvarez-Horine S, Wang, YG, Spaeth M. Effects of Sodium Oxybate on Pain, Function, and PGIC in Fibromyalgia: Results From an International, 14-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial. [AAPM abstract 186]. Pain Med. 2010;11(2):317.

ReferenceCitation: Swick TJ, Spaeth M, Choy EH, Alvarez-Horine S, Wang YG, Benson B, Bennett R. Sodium Oxybate Reduces Pain and Improves Function and PGIC in Fibromyalgia: Results From an International, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial [AAN abstract P03.293]. Neurology. 2010;74(suppl 2):A280.

ReferenceCitation: Bennett RM, Rosenthal N, Lai C, Benson B, Wang YG, Alegre C, Perrot S.. Functionality and Quality of Life Are Improved in Fibromyalgia Patients Treated With Sodium Oxybate: Results From a Phase 3 International Trial. In: American Psychiatric Association New Research Abstracts to the 2010 Annual Meeting; May 22-26, 2010; New Orleans, LA. Abstract NR7-49.

ReferenceCitation: Swick TJ, Curtis C, Benson B, Lai C, Wang YG, Rothman J, Sarzi-Puttini P. Fibromyalgia Patients Have Impaired Sleep and Daytime Functioning at Baseline: Data From an International Phase 3 Trial of Sodium Oxybate [APSS abstract 0882]. Sleep. 2010;33(suppl):A295.

ReferenceCitation: Swick TJ, Lai C, Benson B, Wang YG, Sarzi-Puttini P. Fibromyalgia Pain, Fatigue, and Sleep Improve With Sodium Oxybate Treatment: A 14-Week Randomized, Double-Blind, Placebo-Controlled International Trial [APSS abstract 0883]. Sleep. 2010;33(suppl):A295.

ReferenceCitation: Choy E, Alegre C, Sarzi-Puttini P, van Seventer R, Wang YG, Guinta D, Lai C, Bennett R and the Oxybate in Fibromyalgia 06-009 Study Group. The Effects of Sodium Oxybate on Sleep Disturbance, Fatigue, and Functioning in Fibromyalgia: Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled International Trial [FRI10411]. Ann Rheum Dis. 2010;69(suppl 3):449.

ReferenceCitation: Spaeth M, Perrot S, Samborski W, Bazzichi L, van de Laar M, Guinta D, Wang YG, Lai C, Bennett R and Sodium Oxybate in Fibromyalgia 06-009 Study Group. Sodium Oxybate Treatment Improves Pain, Function, and Patient Global Impression of Change (PGIC) in Fibromyalgia Patients: Results From an International, Randomized, Double-Blind, Placebo-Controlled Trial. Ann Rheum Dis. 2010;69(suppl 3):449

lead_sponsor: Jazz Pharmaceuticals

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
United States
France
Germany

location_facility: Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie

location_facility: Praxis fur Innere Medizin und Rheumatologie

location_facility: Arthritis & Osteoporosis Center of South Texas

location_facility: Barnsley District General Hospital, Rheumatology Department

location_facility: North Orange County Research Institute, Inc.

location_facility: Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU

location_facility: Hopital Hotel Dieu service de medecine interne

location_facility: Ohio State U, Immunology/Rheumatology William Davis Medical Research Center

location_facility: Rheumazentrum am Krankenhaus Bad Doberan

location_facility: Arthritis and Osteoporosis Clinic, Research Center of Central Texas

location_facility: Center for Musculoskeletal Pain Research

location_facility: Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis

location_facility: Royal National Hospital for Rheumatic Diseases NHS

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny

location_facility: University of Texas Health Science Center

location_facility: Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord

location_facility: Cleveland Neuro-Sleep Research Institute Inc.

location_facility: Oregon Health Sciences University School of Medicine

location_facility: Central Kentucky Research Associates,Inc.

location_facility: Clinical Research Group of St. Petersburg, Inc.

location_facility: Hopital Claude Huriez Service de medecine Interne

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: North Shore University Hospital, North Shore Pain Services

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Professional Clinical Research at Cyrstal Lake Health Center

location_facility: Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny

location_facility: Florida Medical Clinic, P.A., Clinical Research Division

location_facility: Fibromyalgia Treatment Centers of America

location_facility: Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara

location_facility: Professional Clinical Research at Crystal Lake Health Center