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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00371137
First received: August 30, 2006
Last updated: December 21, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Fibromyalgia
Drug: Xyrem®
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 548
Study Start Date: August 2006
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Oral Solution
Experimental: 2 Drug: Xyrem®
two doses

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371137

  Hide Study Locations
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
Arizona Research Center
Phoenix, Arizona, United States, 85023
Xenoscience, Inc. dba 21st Century Neurology
Phoenix, Arizona, United States, 85004
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
Clinvest
Springfield, Missouri, United States, 65807
St. John's Mercy Health System
St. Louis, Missouri, United States, 63141
Clayton Medical Associates
St. Louis, Missouri, United States, 63117
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
Carolinas Research
Charlotte, North Carolina, United States, 28226
Carolina Bone and Joint
Charlotte, North Carolina, United States, 28210
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
Clinsearch
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
Radiant Research San Antonio Northeast
San Antonio, Texas, United States, 78217
Sun Research Institute
San Antonio, Texas, United States, 78205
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
Investigators
Principal Investigator: I. Jon Russell, PhD, MD The University of Texas Health Science Center at San Antonio
  More Information

Publications:
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.

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00371137     History of Changes
Other Study ID Numbers: 06-008
Study First Received: August 30, 2006
Results First Received: September 8, 2011
Last Updated: December 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Jazz Pharmaceuticals:
FMS
Fibro
pain
Body pain
tenderness
joint pain
stiffness
muscular pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014