A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
- Registration Number
- NCT00371137
- 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-one (21) 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 one (1) week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication acetaminophen (up to 4 grams per day) will be allowed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 548
- 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 1 Placebo - 2 Xyrem® -
- 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 (69)
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Carolinas Research
🇺🇸Charlotte, North Carolina, United States
Graves - Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Clayton Medical Associates
🇺🇸St. Louis, Missouri, United States
Commonwealth Biomedical Reseach, LLC
🇺🇸Madisonville, Kentucky, United States
Radiant Research, Greer
🇺🇸Greer, South Carolina, United States
Great Lakes Medical Research
🇺🇸Westfield, New York, United States
PCM Medical Services
🇺🇸Lansing, Michigan, United States
St. John's Mercy Health System
🇺🇸St. Louis, Missouri, United States
Central Pennsylvania Clinical Research
🇺🇸Mechanicsburg, Pennsylvania, United States
Upstate Clinical Research, LLC
🇺🇸Albany, New York, United States
Medford Medical Clinic, LLP
🇺🇸Medford, Oregon, United States
Carolina Bone and Joint
🇺🇸Charlotte, North Carolina, United States
FutureCare Studies
🇺🇸Springfield, Massachusetts, United States
Tulsa Clinical Research, LLC
🇺🇸Tulsa, Oklahoma, United States
School of Osteopathic Medicine
🇺🇸Cherry Hill, New Jersey, United States
Clinsearch
🇺🇸Chattanooga, Tennessee, United States
Anderson & Collins Clinical Research, Inc.
🇺🇸Edison, New Jersey, United States
Signal Point Clinical Research Center, LLC
🇺🇸Middletown, Ohio, United States
Clinical Research Source, Inc.
🇺🇸Perrysburg, Ohio, United States
CCR Trials
🇺🇸Berlin, New Jersey, United States
PRO Research
🇺🇸Eugene, Oregon, United States
Richard A. Neiman, MD, Inc.
🇺🇸Kirkland, Washington, United States
Walter M. Chase, MD
🇺🇸Austin, Texas, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Rheumatology Consultants, PLLC
🇺🇸Knoxville, Tennessee, United States
Pacific Rheumatolgy Associates, Inc.
🇺🇸Renton, Washington, United States
Xenoscience, Inc. dba 21st Century Neurology
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Investigative Clinical Research of Indiana, LLC
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Health Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
The Methodist Hospital Systems
🇺🇸Houston, Texas, United States
Houston Sleep Center
🇺🇸Houston, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Radiant Research San Antonio Northeast
🇺🇸San Antonio, Texas, United States
The University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
DFW Wellness
🇺🇸Fort Worth, Texas, United States
Clinvest
🇺🇸Springfield, Missouri, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Rheumatology Associates of N. AL, PC
🇺🇸Huntsville, Alabama, United States
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
Northern California Research
🇺🇸Carmichael, California, United States
Pasadena Rehabilitation Institute
🇺🇸Pasadena, California, United States
Arroyo Medical Group
🇺🇸Pismo Beach, California, United States
Clinical Physiology Associates Clinical Study Center
🇺🇸Fort Meyers, Florida, United States
Apex Research Institute
🇺🇸Santa Ana, California, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Innovative Research
🇺🇸Largo, Florida, United States
Coastal Medical Research, Inc
🇺🇸Port Orange, Florida, United States
Robert E. Harris, MD Medical Corporation
🇺🇸Whittier, California, United States
Sunrise Medical Research
🇺🇸Plantation, Florida, United States
CRIA Research
🇺🇸Ft. Lauderdale, Florida, United States
Welborn Clinic
🇺🇸Evansville, Indiana, United States
Deerpath Physicians Group
🇺🇸Gurnee, Illinois, United States
Balanced health Research Center
🇺🇸Peoria, Illinois, United States
Charrleston Internal Medicine
🇺🇸Charleston, West Virginia, United States
Fatigue Consultation Center
🇺🇸Salt Lake City, Utah, United States
Compass Research
🇺🇸Orlando, Florida, United States
Future Search Trials of Neurology Future Research Trials
🇺🇸Austin, Texas, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Central Kentucky Research Associates, Inc.
🇺🇸Lexington, Kentucky, United States
Sacramento Research Medical Group
🇺🇸Sacramento, California, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Low Country Research Center
🇺🇸Charleston, South Carolina, United States
Radiant Research
🇺🇸Mogadore, Ohio, United States