A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
1 other identifier
interventional
548
1 country
70
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2006
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 30, 2006
CompletedFirst Posted
Study publicly available on registry
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
November 30, 2011
CompletedDecember 29, 2011
December 1, 2011
2.1 years
August 30, 2006
September 8, 2011
December 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
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
Study Arms (2)
1
PLACEBO COMPARATOR2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
You may not qualify if:
- Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Rheumatology Associates of N. AL, PC
Huntsville, Alabama, 35801, United States
Xenoscience, Inc. dba 21st Century Neurology
Phoenix, Arizona, 85004, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Providence Clinical Research
Burbank, California, 91505, United States
Northern California Research
Carmichael, California, 95608, United States
Pasadena Rehabilitation Institute
Pasadena, California, 91105, United States
Arroyo Medical Group
Pismo Beach, California, 93449, United States
Sacramento Research Medical Group
Sacramento, California, 95825, United States
Apex Research Institute
Santa Ana, California, 92705, United States
Sansum Clinic
Santa Barbara, California, 93110, United States
Robert E. Harris, MD Medical Corporation
Whittier, California, 90601, United States
CRIA Research
Fort Lauderdale, Florida, 33334, United States
Clinical Physiology Associates Clinical Study Center
Fort Meyers, Florida, 33916, United States
Innovative Research
Largo, Florida, 33770, United States
Compass Research
Orlando, Florida, 32806, United States
Sunrise Medical Research
Plantation, Florida, 33317, United States
Coastal Medical Research, Inc
Port Orange, Florida, 32127, United States
Deerpath Physicians Group
Gurnee, Illinois, 60031, United States
Balanced health Research Center
Peoria, Illinois, 61614, United States
Welborn Clinic
Evansville, Indiana, 47713, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46254, United States
Graves - Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Commonwealth Biomedical Reseach, LLC
Madisonville, Kentucky, 42431, United States
FutureCare Studies
Springfield, Massachusetts, 01103, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
PCM Medical Services
Lansing, Michigan, 48917, United States
Clinvest
Springfield, Missouri, 65807, United States
Clayton Medical Associates
St Louis, Missouri, 63117, United States
St. John's Mercy Health System
St Louis, Missouri, 63141, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
CCR Trials
Berlin, New Jersey, 08009, United States
School of Osteopathic Medicine
Cherry Hill, New Jersey, 08002, United States
Anderson & Collins Clinical Research, Inc.
Edison, New Jersey, 08817, United States
Upstate Clinical Research, LLC
Albany, New York, 12205, United States
AAIR Research Center
Rochester, New York, 14618, United States
Great Lakes Medical Research
Westfield, New York, 14787, United States
Carolina Bone and Joint
Charlotte, North Carolina, 28210, United States
Carolinas Research
Charlotte, North Carolina, 28226, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Radiant Research
Columbus, Ohio, 43212, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Radiant Research
Mogadore, Ohio, 44260, United States
Clinical Research Source, Inc.
Perrysburg, Ohio, 43551, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104, United States
PRO Research
Eugene, Oregon, 97401, United States
Medford Medical Clinic, LLP
Medford, Oregon, 97504, United States
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, 17055, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Low Country Research Center
Charleston, South Carolina, 29406, United States
Radiant Research, Greer
Greer, South Carolina, 29651, United States
Clinsearch
Chattanooga, Tennessee, 37421, United States
Rheumatology Consultants, PLLC
Knoxville, Tennessee, 37909, United States
Walter M. Chase, MD
Austin, Texas, 78705, United States
Future Search Trials of Neurology Future Research Trials
Austin, Texas, 78756, United States
DFW Wellness
Fort Worth, Texas, 76108, United States
The Methodist Hospital Systems
Houston, Texas, 77030, United States
Houston Sleep Center
Houston, Texas, 77063, United States
Sun Research Institute
San Antonio, Texas, 78205, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, 78217, United States
The University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Fatigue Consultation Center
Salt Lake City, Utah, 84102, United States
Richard A. Neiman, MD, Inc.
Kirkland, Washington, 98034, United States
Pacific Rheumatolgy Associates, Inc.
Renton, Washington, 98055, United States
Charrleston Internal Medicine
Charleston, West Virginia, 25304, United States
Related Publications (10)
Russell JI, Holman AJ, Swick TJ, Alvarez-Horine S, Wang GY, Guinta D; Sodium Oxybate 06-008 FM Study Group. Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: results from a 14-week, randomized, double-blind, placebo-controlled study. Pain. 2011 May;152(5):1007-1017. doi: 10.1016/j.pain.2010.12.022. Epub 2011 Mar 11.
PMID: 21397402RESULTSwick 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.
RESULTSwick 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.
RESULTMease 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.
RESULTRussell 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.
RESULTSwick 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.
RESULTJones 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.
RESULTRussell IJ, Perkins AT, Michalek JE; Oxybate SXB-26 Fibromyalgia Syndrome Study Group. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2009 Jan;60(1):299-309. doi: 10.1002/art.24142.
PMID: 19116896RESULTSilverman 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.
RESULTSpaeth 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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grace Wang, MD, Medical Monitor & Director of Clinical Development
- Organization
- Jazz Pharmaceuticals, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
I. Jon Russell, PhD, MD
The University of Texas Health Science Center at San Antonio
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2006
First Posted
September 1, 2006
Study Start
August 1, 2006
Primary Completion
September 1, 2008
Study Completion
December 1, 2008
Last Updated
December 29, 2011
Results First Posted
November 30, 2011
Record last verified: 2011-12