A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371137
Recruitment Status : Completed
First Posted : September 1, 2006
Results First Posted : November 30, 2011
Last Update Posted : December 29, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Xyrem® Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 548 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
Study Start Date : August 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
Oral Solution
Experimental: 2 Drug: Xyrem®
two doses

Primary Outcome Measures :
  1. Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00371137

  Hide Study Locations
United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
Rheumatology Associates of N. AL, PC
Huntsville, Alabama, United States, 35801
United States, Arizona
Xenoscience, Inc. dba 21st Century Neurology
Phoenix, Arizona, United States, 85004
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Providence Clinical Research
Burbank, California, United States, 91505
Northern California Research
Carmichael, California, United States, 95608
Pasadena Rehabilitation Institute
Pasadena, California, United States, 91105
Arroyo Medical Group
Pismo Beach, California, United States, 93449
Sacramento Research Medical Group
Sacramento, California, United States, 95825
Apex Research Institute
Santa Ana, California, United States, 92705
Sansum Clinic
Santa Barbara, California, United States, 93110
Robert E. Harris, MD Medical Corporation
Whittier, California, United States, 90601
United States, Florida
Clinical Physiology Associates Clinical Study Center
Fort Meyers, Florida, United States, 33916
CRIA Research
Ft. Lauderdale, Florida, United States, 33334
Innovative Research
Largo, Florida, United States, 33770
Compass Research
Orlando, Florida, United States, 32806
Sunrise Medical Research
Plantation, Florida, United States, 33317
Coastal Medical Research, Inc
Port Orange, Florida, United States, 32127
United States, Illinois
Deerpath Physicians Group
Gurnee, Illinois, United States, 60031
Balanced health Research Center
Peoria, Illinois, United States, 61614
United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 47713
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, United States, 46254
United States, Kentucky
Graves - Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
Commonwealth Biomedical Reseach, LLC
Madisonville, Kentucky, United States, 42431
United States, Massachusetts
FutureCare Studies
Springfield, Massachusetts, United States, 01103
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Michigan
PCM Medical Services
Lansing, Michigan, United States, 48917
United States, Missouri
Springfield, Missouri, United States, 65807
Clayton Medical Associates
St. Louis, Missouri, United States, 63117
St. John's Mercy Health System
St. Louis, Missouri, United States, 63141
United States, Nebraska
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
United States, New Jersey
CCR Trials
Berlin, New Jersey, United States, 08009
School of Osteopathic Medicine
Cherry Hill, New Jersey, United States, 08002
Anderson & Collins Clinical Research, Inc.
Edison, New Jersey, United States, 08817
United States, New York
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
AAIR Research Center
Rochester, New York, United States, 14618
Great Lakes Medical Research
Westfield, New York, United States, 14787
United States, North Carolina
Carolina Bone and Joint
Charlotte, North Carolina, United States, 28210
Carolinas Research
Charlotte, North Carolina, United States, 28226
Duke University Medical Center
Durham, North Carolina, United States, 27705
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Radiant Research
Columbus, Ohio, United States, 43212
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States, 45042
Radiant Research
Mogadore, Ohio, United States, 44260
Clinical Research Source, Inc.
Perrysburg, Ohio, United States, 43551
United States, Oklahoma
Health Research Institute
Oklahoma City, Oklahoma, United States, 73109
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States, 74104
United States, Oregon
PRO Research
Eugene, Oregon, United States, 97401
Medford Medical Clinic, LLP
Medford, Oregon, United States, 97504
United States, Pennsylvania
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, United States, 17055
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Low Country Research Center
Charleston, South Carolina, United States, 29406
Radiant Research, Greer
Greer, South Carolina, United States, 29651
United States, Tennessee
Chattanooga, Tennessee, United States, 37421
Rheumatology Consultants, PLLC
Knoxville, Tennessee, United States, 37909
United States, Texas
Walter M. Chase, MD
Austin, Texas, United States, 78705
Future Search Trials of Neurology Future Research Trials
Austin, Texas, United States, 78756
DFW Wellness
Fort Worth, Texas, United States, 76108
The Methodist Hospital Systems
Houston, Texas, United States, 77030
Houston Sleep Center
Houston, Texas, United States, 77063
Sun Research Institute
San Antonio, Texas, United States, 78205
Radiant Research San Antonio Northeast
San Antonio, Texas, United States, 78217
The University of Texas Health Science Center
San Antonio, Texas, United States, 78229
United States, Utah
Fatigue Consultation Center
Salt Lake City, Utah, United States, 84102
United States, Washington
Richard A. Neiman, MD, Inc.
Kirkland, Washington, United States, 98034
Pacific Rheumatolgy Associates, Inc.
Renton, Washington, United States, 98055
United States, West Virginia
Charrleston Internal Medicine
Charleston, West Virginia, United States, 25304
Sponsors and Collaborators
Jazz Pharmaceuticals
Principal Investigator: I. Jon Russell, PhD, MD The University of Texas Health Science Center at San Antonio

Publications of Results:
Swick TJ, Alvarez-Horine S, Zheng Y, Rothman J, Inhaber N, Holman AJ, Smith TR, Russell IJ. Sodium Oxybate Improves Pain, Fatigue, and Sleep in Fibromyalgia: Results from a 14-Week Randomized, Double-Blind, Placebo-Controlled Trial. [APSS abstract 0984]. Sleep 2009;32(suppl):A321.
Swick TJ, Alvarez-Horine S, Zheng Y, Guinta D, Inhaber N, Holman AJ, Smith TR, Russell IJ. Impaired Sleep and Daytime Functioning at Baseline in Subjects with Fibromyalgia from a 14-Week Randomized, Double-Blind, Placebo-Controlled Trial of Sodium Oxybate. [APSS abstract 1013]. Sleep 2009;32(suppl):A330.
Mease PJ, Swick TJ, Alvarez-Horine S, Inhaber N, Guinta DR, Holman AJ, and Russell IJ. Sodium Oxybate Improves Fatigue, Sleep Disturbance, and PGIC in Fibromyalgia-Results form a Phase 3, 14-Week, Controlled Trial. Arthritis & Rheum 2009;60(10):S529.
Russell IJ, Alvarez-Horine S, Zheng Y, Guinta DR, Holman AJ and Swick TJ. Effect of Sodium Oxybate on Pain, PGIC, & Composite Scores in Fibromyalgia-Results from a Phase 3 Controlled Trial. Arthritis & Rheum 2009;60(10):S528.
Swick TJ, Rosenfeld V, Alvarez-Horine S, Guinta D, Wang YG, Russell IJ. Improvement in Multiple Symptoms of Fibromyalgia With Sodium Oxybate Treatment: Results From a US Phase 3 Randomized, Controlled Trial [AAN abstract P03.292]. Neurology. 2010;74(suppl 2):A279.
Jones KD, Bennett RM, Alvarez-Horine S, Wang YG, Guinta D, Russell IJ. Sodium Oxybate Improves Function and Quality of Life in Fibromyalgia—Results From a Phase 3, Randomized, Controlled Trial [APS abstract 262]. J Pain. 2010;11(suppl 1):S41.
Silverman S, Holman AJ, Benson B, Alvarez-Horine S, Wang YG, Sarzi-Puttini. Sodium Oxybate Improves Sleep and Fatigue in Patients With Fibromyalgia: Pooled Analysis From 2 Pivotal Clinical Trials [ACR/ARHP abstract 2337]. Arthritis Rheum. 2010;62(suppl 10):815.
Spaeth M, Russell IJ, Perrot S, Choy E, Benson B, Wang YG, Lai C. The Effects of Sodium Oxybate on Multiple Symptoms of Fibromyalgia: Results From Two Phase 3, Randomized, Double-Blind, Controlled Trials. In: Myopain 2010 Abstracts; October 3-7, 2010; Toledo, Spain. Abstract 39.

Responsible Party: Jazz Pharmaceuticals Identifier: NCT00371137     History of Changes
Other Study ID Numbers: 06-008
First Posted: September 1, 2006    Key Record Dates
Results First Posted: November 30, 2011
Last Update Posted: December 29, 2011
Last Verified: December 2011

Keywords provided by Jazz Pharmaceuticals:
Body pain
joint pain
muscular pain

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs