Fibromyalgia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Verified date | December 2011 |
Source | Jazz Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 573 |
Est. completion date | June 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia. Exclusion Criteria: - Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms. - Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Rhumatologie | Amiens Cedex 1 | |
France | CHU de Grenoble-hopital Sud | Echirolles Cedex | |
France | Hopital Claude Huriez Service de medecine Interne | Lille Cedex | |
France | Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord | Nantes Cedex 2 | |
France | Hopital Pasteue - Pavillon O | Nice Cedex 1 | |
France | Hopital Hotel Dieu service de medecine interne | Paris Cedex 04 | |
France | CHU Hopital de Rangueil | Toulouse Cedex 9 | |
Germany | Schlosspark-Klinik | Berlin | |
Germany | Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie | Boblingen | |
Germany | Praxis Dr. Wiedeking | Essen | |
Germany | Praxis fur Innere Medizin und Rheumatologie | Grafelfing | |
Germany | Gemeinschaftspraxis Schmerzzentrum | Hamburg | |
Germany | Rheumazentrum am Krankenhaus Bad Doberan | Hohenfelde - Bad Doberan | |
Germany | Intensivmedizin der Uniklinik Koln | Koln | |
Germany | Praxisklinik Dr. Weiss | Mannheim | |
Germany | Praxis Dr. Sohn | Schwalmtal | |
Italy | Azienda Ospedaliera Luigi Sacco | Milano | |
Italy | Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara | Pisa | |
Netherlands | Amphia Ziekenhuis | Breda | |
Netherlands | Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis | Enschede | |
Poland | Wojewodzki Szpital Zespolony | Elblag | |
Poland | Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny | Katowice | |
Poland | Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny | Poznan | |
Poland | w Szczecinie | Szczecinie | |
Poland | NZOZ Nasz Lekarz | Torun | |
Poland | Instytut Reumatologii | Warszawa | |
Spain | Hospital Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | Instituto Ferran de Reumatologia | Barcelona | |
Spain | Hospital Universitario de Guadalajara | Guadalajara | |
Spain | Hospital Universitario de Canarias | La Laguna | |
Spain | Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | |
Spain | Hospital Civil de malaga | Malaga | |
Spain | Hospital Central de Asturias | Oviedo | |
Spain | Hospital Clinico Universitario de Santiago | Santiago de Compostela | |
United Kingdom | Barnsley District General Hospital, Rheumatology Department | Barnsley | |
United Kingdom | Royal National Hospital for Rheumatic Diseases NHS | Bath | |
United Kingdom | Lever Chambers Centre for Health | Bolton | |
United Kingdom | 4 West Kennedy Clinical Trial unit | London | |
United Kingdom | King College London | London | |
United Kingdom | King's College London | London | |
United Kingdom | Freeman Hospital | Newcastle | |
United Kingdom | Freeman Hospital | Newcastle upon tyne | |
United Kingdom | Philip Arnold Unit | Poole | |
United Kingdom | Poole General Hospital | Poole | |
United States | Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico |
United States | Orange County Clinical Trials | Anaheim | California |
United States | Alben Goldstein, MD, FACP | Arlington | Virginia |
United States | East Alabama Arthritis Center | Auburn | Alabama |
United States | Neurology Future Research Trials | Austin | Texas |
United States | Louisiana Sleep Foundation | Baton Rouge | Louisiana |
United States | Tri State Medical Group, Inc. | Beaver | Pennsylvania |
United States | Professional Clinical Research at Cyrstal Lake Health Center | Benzonia | Michigan |
United States | Comprehensive Clinical Research | Berlin | New Jersey |
United States | Quest Research Institute | Bingham Farms | Michigan |
United States | Capstone Clinical Trials, Inc. | Birmingham | Alabama |
United States | Appalachian Regional Medical Associates | Boone | North Carolina |
United States | Providence Clinical Research | Burbank | California |
United States | Professional Clinical Research | Cadillac | Michigan |
United States | Fibromyalgia Treatment Centers of America | Chicago | Illinois |
United States | Hightop Medical Research Center | Cincinnati | Ohio |
United States | Health Research Associates, LLC (HRA) | Cleveland | Ohio |
United States | Coeur d'Alene Arthritis Clinic | Coeur d'Alene | Idaho |
United States | Southern Orthopaedic Sports Medicine | Columbia | South Carolina |
United States | Ohio State U, Immunology/Rheumatology William Davis Medical Research Center | Columbus | Ohio |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
United States | Alan Lichtbroun, MD | East Brunswick | New Jersey |
United States | Center for Arthritis and Osteoporosis | Elizabethtown | Kentucky |
United States | Med Investigations, Inc. | Fair Oaks | California |
United States | University of CT, Health Center | Farmington | Connecticut |
United States | DFW Wellness | Fort Worth | Texas |
United States | North Orange County Research Institute, Inc. | Fullerton | California |
United States | Center for Musculoskeletal Pain Research | Gainesville | Florida |
United States | Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU | Greenville | North Carolina |
United States | Arthritis Associates | Hattiesburg | Mississippi |
United States | Houston Sleep Center | Houston | Texas |
United States | R/D Clinical Research, Inc. | Houston | Texas |
United States | The Methodist Hospital System | Houston | Texas |
United States | Investigative Clinical Research of Indiana, LLC | Indianapolis | Indiana |
United States | Professional Clinical Research at Crystal Lake Health Center | Interlochen | Michigan |
United States | Nerve Pro Research | Irvine | California |
United States | Florida Institute of Medical Research | Jacksonville | Florida |
United States | Suncoast Internal Medicine Consultants | Largo | Florida |
United States | Central Kentucky Research Associates,Inc. | Lexington | Kentucky |
United States | Drug Studies America | Marietta | Georgia |
United States | AppleMed Research | Miami | Florida |
United States | Cleveland Neuro-Sleep Research Institute Inc. | Middleburg Heights | Ohio |
United States | Drug Research and Analysis Corporation | Montgomery | Alabama |
United States | Northridge Neurological Center | Northridge | California |
United States | Quality Clinical Research, Inc. | Omaha | Nebraska |
United States | Compass Research | Orlando | Florida |
United States | Bluegrass Internal Medicine | Owensboro | Kentucky |
United States | dba 21st Century Neurology | Phoenix | Arizona |
United States | Arroyo Medical Group | Pismo Beach | California |
United States | Oregon Health Sciences University School of Medicine | Portland | Oregon |
United States | Summit Research Network (Oregon) Inc. | Portland | Oregon |
United States | Capital Clinical Research Associates | Rockville | Maryland |
United States | Northern California Research | Sacramento | California |
United States | Sacramento Research Medical Group | Sacramento | California |
United States | Arthritis & Osteoporosis Center of South Texas | San Antonio | Texas |
United States | Sun Research Institute | San Antonio | Texas |
United States | University of Texas Health Science Center | San Antonio | Texas |
United States | Medex Healthcare Research, Inc | St. louis | Missouri |
United States | St. John's Mercy Health System | St. Louis | Missouri |
United States | Clinical Research Group of St. Petersburg, Inc. | St. Petersburg | Florida |
United States | Clinical Health Research, LLC | Sugarland | Texas |
United States | Tampa Medical Group, P.A. | Tampa | Florida |
United States | Lake Rheumatology | Tavares | Florida |
United States | Cotton-O'neil Clinical Research center | Topeka | Kansas |
United States | North Shore University Hospital, North Shore Pain Services | Valley Stream | New York |
United States | Center for Arthritis and Rheumatism | Vero Beach | Florida |
United States | Arthritis and Osteoporosis Clinic, Research Center of Central Texas | Waco | Texas |
United States | Great Lakes Medical Research | Westfield | New York |
United States | The Center for Clinical Research | Winston-Salem | North Carolina |
United States | Founders Research | Yardley | Pennsylvania |
United States | Florida Medical Clinic, P.A., Clinical Research Division | Zephyrhills | Florida |
Lead Sponsor | Collaborator |
---|---|
Jazz Pharmaceuticals |
United States, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom,
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. [
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 N
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
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 Fibr
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)
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.
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 abstra
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). | Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14. | Baseline to Week 14 | No |
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