A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
- Registration Number
- NCT00423813
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief 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.
- Detailed Description
The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-two (22) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) will be allowed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 573
- Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Xyrem® - 1 placebo -
- Primary Outcome Measures
Name Time Method Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). Baseline to Week 14 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (115)
Drug Studies America
🇺🇸Marietta, Georgia, United States
Louisiana Sleep Foundation
🇺🇸Baton Rouge, Louisiana, United States
Medex Healthcare Research, Inc
🇺🇸St. louis, Missouri, United States
North Orange County Research Institute, Inc.
🇺🇸Fullerton, California, United States
Bluegrass Internal Medicine
🇺🇸Owensboro, Kentucky, United States
Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU
🇺🇸Greenville, North Carolina, United States
Ohio State U, Immunology/Rheumatology William Davis Medical Research Center
🇺🇸Columbus, Ohio, United States
Fibromyalgia Treatment Centers of America
🇺🇸Chicago, Illinois, United States
East Alabama Arthritis Center
🇺🇸Auburn, Alabama, United States
Florida Institute of Medical Research
🇺🇸Jacksonville, Florida, United States
University of CT, Health Center
🇺🇸Farmington, Connecticut, United States
Hospital Civil de malaga
🇪🇸Malaga, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Barnsley District General Hospital, Rheumatology Department
🇬🇧Barnsley, United Kingdom
AppleMed Research
🇺🇸Miami, Florida, United States
Houston Sleep Center
🇺🇸Houston, Texas, United States
Investigative Clinical Research of Indiana, LLC
🇺🇸Indianapolis, Indiana, United States
Health Research Associates, LLC (HRA)
🇺🇸Cleveland, Ohio, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
R/D Clinical Research, Inc.
🇺🇸Houston, Texas, United States
dba 21st Century Neurology
🇺🇸Phoenix, Arizona, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
Arthritis & Osteoporosis Center of South Texas
🇺🇸San Antonio, Texas, United States
Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara
🇮🇹Pisa, Italy
King's College London
🇬🇧London, United Kingdom
Tampa Medical Group, P.A.
🇺🇸Tampa, Florida, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Summit Research Network (Oregon) Inc.
🇺🇸Portland, Oregon, United States
Oregon Health Sciences University School of Medicine
🇺🇸Portland, Oregon, United States
Capstone Clinical Trials, Inc.
🇺🇸Birmingham, Alabama, United States
Drug Research and Analysis Corporation
🇺🇸Montgomery, Alabama, United States
Orange County Clinical Trials
🇺🇸Anaheim, California, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
Med Investigations, Inc.
🇺🇸Fair Oaks, California, United States
Arroyo Medical Group
🇺🇸Pismo Beach, California, United States
Nerve Pro Research
🇺🇸Irvine, California, United States
Northridge Neurological Center
🇺🇸Northridge, California, United States
Center for Musculoskeletal Pain Research
🇺🇸Gainesville, Florida, United States
Clinical Research Group of St. Petersburg, Inc.
🇺🇸St. Petersburg, Florida, United States
Suncoast Internal Medicine Consultants
🇺🇸Largo, Florida, United States
Center for Arthritis and Rheumatism
🇺🇸Vero Beach, Florida, United States
Florida Medical Clinic, P.A., Clinical Research Division
🇺🇸Zephyrhills, Florida, United States
Lake Rheumatology
🇺🇸Tavares, Florida, United States
Coeur d'Alene Arthritis Clinic
🇺🇸Coeur d'Alene, Idaho, United States
Central Kentucky Research Associates,Inc.
🇺🇸Lexington, Kentucky, United States
Cotton-O'neil Clinical Research center
🇺🇸Topeka, Kansas, United States
Center for Arthritis and Osteoporosis
🇺🇸Elizabethtown, Kentucky, United States
Professional Clinical Research at Cyrstal Lake Health Center
🇺🇸Benzonia, Michigan, United States
Capital Clinical Research Associates
🇺🇸Rockville, Maryland, United States
Professional Clinical Research at Crystal Lake Health Center
🇺🇸Interlochen, Michigan, United States
Quest Research Institute
🇺🇸Bingham Farms, Michigan, United States
Professional Clinical Research
🇺🇸Cadillac, Michigan, United States
Arthritis Associates
🇺🇸Hattiesburg, Mississippi, United States
St. John's Mercy Health System
🇺🇸St. Louis, Missouri, United States
Alan Lichtbroun, MD
🇺🇸East Brunswick, New Jersey, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
North Shore University Hospital, North Shore Pain Services
🇺🇸Valley Stream, New York, United States
Great Lakes Medical Research
🇺🇸Westfield, New York, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Appalachian Regional Medical Associates
🇺🇸Boone, North Carolina, United States
Cleveland Neuro-Sleep Research Institute Inc.
🇺🇸Middleburg Heights, Ohio, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Tri State Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
Founders Research
🇺🇸Yardley, Pennsylvania, United States
DFW Wellness
🇺🇸Fort Worth, Texas, United States
The Methodist Hospital System
🇺🇸Houston, Texas, United States
Southern Orthopaedic Sports Medicine
🇺🇸Columbia, South Carolina, United States
Arthritis and Osteoporosis Clinic, Research Center of Central Texas
🇺🇸Waco, Texas, United States
Rhumatologie
🇫🇷Amiens Cedex 1, France
Clinical Health Research, LLC
🇺🇸Sugarland, Texas, United States
Alben Goldstein, MD, FACP
🇺🇸Arlington, Virginia, United States
Hopital Claude Huriez Service de medecine Interne
🇫🇷Lille Cedex, France
Praxis Dr. Wiedeking
🇩🇪Essen, Germany
Hopital Pasteue - Pavillon O
🇫🇷Nice Cedex 1, France
CHU de Grenoble-hopital Sud
🇫🇷Echirolles Cedex, France
Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord
🇫🇷Nantes Cedex 2, France
Hopital Hotel Dieu service de medecine interne
🇫🇷Paris Cedex 04, France
Schlosspark-Klinik
🇩🇪Berlin, Germany
CHU Hopital de Rangueil
🇫🇷Toulouse Cedex 9, France
Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie
🇩🇪Boblingen, Germany
Gemeinschaftspraxis Schmerzzentrum
🇩🇪Hamburg, Germany
Praxis fur Innere Medizin und Rheumatologie
🇩🇪Grafelfing, Germany
Rheumazentrum am Krankenhaus Bad Doberan
🇩🇪Hohenfelde - Bad Doberan, Germany
Intensivmedizin der Uniklinik Koln
🇩🇪Koln, Germany
Praxisklinik Dr. Weiss
🇩🇪Mannheim, Germany
Azienda Ospedaliera Luigi Sacco
🇮🇹Milano, Italy
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Praxis Dr. Sohn
🇩🇪Schwalmtal, Germany
Wojewodzki Szpital Zespolony
🇵🇱Elblag, Poland
NZOZ Nasz Lekarz
🇵🇱Torun, Poland
Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis
🇳🇱Enschede, Netherlands
Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny
🇵🇱Poznan, Poland
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny
🇵🇱Katowice, Poland
w Szczecinie
🇵🇱Szczecinie, Poland
Instytut Reumatologii
🇵🇱Warszawa, Poland
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Spain
Hospital Universitario de Guadalajara
🇪🇸Guadalajara, Spain
Instituto Ferran de Reumatologia
🇪🇸Barcelona, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
🇪🇸Las Palmas de Gran Canaria, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
King College London
🇬🇧London, United Kingdom
Royal National Hospital for Rheumatic Diseases NHS
🇬🇧Bath, United Kingdom
4 West Kennedy Clinical Trial unit
🇬🇧London, United Kingdom
Lever Chambers Centre for Health
🇬🇧Bolton, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
Poole General Hospital
🇬🇧Poole, United Kingdom
Philip Arnold Unit
🇬🇧Poole, United Kingdom
Northern California Research
🇺🇸Sacramento, California, United States
Sacramento Research Medical Group
🇺🇸Sacramento, California, United States
Compass Research
🇺🇸Orlando, Florida, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Neurology Future Research Trials
🇺🇸Austin, Texas, United States