Fibromyalgia Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
Verified date | December 2011 |
Source | Jazz Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 548 |
Est. completion date | December 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Upstate Clinical Research, LLC | Albany | New York |
United States | Advanced Clinical Research Institute | Anaheim | California |
United States | Pinnacle Research Group, LLC | Anniston | Alabama |
United States | Future Search Trials of Neurology Future Research Trials | Austin | Texas |
United States | Walter M. Chase, MD | Austin | Texas |
United States | CCR Trials | Berlin | New Jersey |
United States | Graves - Gilbert Clinic | Bowling Green | Kentucky |
United States | Providence Clinical Research | Burbank | California |
United States | Northern California Research | Carmichael | California |
United States | Charrleston Internal Medicine | Charleston | West Virginia |
United States | Low Country Research Center | Charleston | South Carolina |
United States | Carolina Bone and Joint | Charlotte | North Carolina |
United States | Carolinas Research | Charlotte | North Carolina |
United States | Clinsearch | Chattanooga | Tennessee |
United States | School of Osteopathic Medicine | Cherry Hill | New Jersey |
United States | Radiant Research | Columbus | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Anderson & Collins Clinical Research, Inc. | Edison | New Jersey |
United States | PRO Research | Eugene | Oregon |
United States | Welborn Clinic | Evansville | Indiana |
United States | Clinical Physiology Associates Clinical Study Center | Fort Meyers | Florida |
United States | DFW Wellness | Fort Worth | Texas |
United States | CRIA Research | Ft. Lauderdale | Florida |
United States | Radiant Research, Greer | Greer | South Carolina |
United States | Deerpath Physicians Group | Gurnee | Illinois |
United States | Houston Sleep Center | Houston | Texas |
United States | The Methodist Hospital Systems | Houston | Texas |
United States | Rheumatology Associates of N. AL, PC | Huntsville | Alabama |
United States | Investigative Clinical Research of Indiana, LLC | Indianapolis | Indiana |
United States | Richard A. Neiman, MD, Inc. | Kirkland | Washington |
United States | Rheumatology Consultants, PLLC | Knoxville | Tennessee |
United States | PCM Medical Services | Lansing | Michigan |
United States | Innovative Research | Largo | Florida |
United States | Central Kentucky Research Associates, Inc. | Lexington | Kentucky |
United States | Commonwealth Biomedical Reseach, LLC | Madisonville | Kentucky |
United States | Central Pennsylvania Clinical Research | Mechanicsburg | Pennsylvania |
United States | Medford Medical Clinic, LLP | Medford | Oregon |
United States | Signal Point Clinical Research Center, LLC | Middletown | Ohio |
United States | Radiant Research | Mogadore | Ohio |
United States | Health Research Institute | Oklahoma City | Oklahoma |
United States | Quality Clinical Research, Inc. | Omaha | Nebraska |
United States | Compass Research | Orlando | Florida |
United States | Pasadena Rehabilitation Institute | Pasadena | California |
United States | Balanced health Research Center | Peoria | Illinois |
United States | Clinical Research Source, Inc. | Perrysburg | Ohio |
United States | Arizona Research Center | Phoenix | Arizona |
United States | Xenoscience, Inc. dba 21st Century Neurology | Phoenix | Arizona |
United States | Arroyo Medical Group | Pismo Beach | California |
United States | Sunrise Medical Research | Plantation | Florida |
United States | Coastal Medical Research, Inc | Port Orange | Florida |
United States | Wake Research Associates, LLC | Raleigh | North Carolina |
United States | Pacific Rheumatolgy Associates, Inc. | Renton | Washington |
United States | AAIR Research Center | Rochester | New York |
United States | Sacramento Research Medical Group | Sacramento | California |
United States | Fatigue Consultation Center | Salt Lake City | Utah |
United States | Radiant Research San Antonio Northeast | San Antonio | Texas |
United States | Sun Research Institute | San Antonio | Texas |
United States | The University of Texas Health Science Center | San Antonio | Texas |
United States | Apex Research Institute | Santa Ana | California |
United States | Sansum Clinic | Santa Barbara | California |
United States | Clinvest | Springfield | Missouri |
United States | FutureCare Studies | Springfield | Massachusetts |
United States | Clayton Medical Associates | St. Louis | Missouri |
United States | St. John's Mercy Health System | St. Louis | Missouri |
United States | Tulsa Clinical Research, LLC | Tulsa | Oklahoma |
United States | Omega Medical Research | Warwick | Rhode Island |
United States | Great Lakes Medical Research | Westfield | New York |
United States | Robert E. Harris, MD Medical Corporation | Whittier | California |
United States | The Center for Clinical Research | Winston-Salem | North Carolina |
United States | Clinical Pharmacology Study Group | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Jazz Pharmaceuticals |
United States,
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.
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.
Russell IJ, Holman AJ, Swick TJ, Alvarez-Horine S, Wang YG, 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- — View Citation
Russell 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 — View Citation
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
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; Tol
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
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].
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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