Clinical trial NCT00371137: A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: FMS
Fibro
pain
Body pain
tenderness
joint pain
stiffness
muscular pain
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-09-01
Enrollment: 548
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).
timeFrame: Baseline to Week 14
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of N. AL, PC
state: Alabama
city: Phoenix
country: United States
facility: Xenoscience, Inc. dba 21st Century Neurology
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Carmichael
country: United States
facility: Northern California Research
state: California
city: Pasadena
country: United States
facility: Pasadena Rehabilitation Institute
state: California
city: Pismo Beach
country: United States
facility: Arroyo Medical Group
state: California
city: Sacramento
country: United States
facility: Sacramento Research Medical Group
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Whittier
country: United States
facility: Robert E. Harris, MD Medical Corporation
state: California
city: Fort Meyers
country: United States
facility: Clinical Physiology Associates Clinical Study Center
state: Florida
city: Ft. Lauderdale
country: United States
facility: CRIA Research
state: Florida
city: Largo
country: United States
facility: Innovative Research
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Plantation
country: United States
facility: Sunrise Medical Research
state: Florida
city: Port Orange
country: United States
facility: Coastal Medical Research, Inc
state: Florida
city: Gurnee
country: United States
facility: Deerpath Physicians Group
state: Illinois
city: Peoria
country: United States
facility: Balanced health Research Center
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Bowling Green
country: United States
facility: Graves - Gilbert Clinic
state: Kentucky
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Reseach, LLC
state: Kentucky
city: Springfield
country: United States
facility: FutureCare Studies
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Lansing
country: United States
facility: PCM Medical Services
state: Michigan
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: St. Louis
country: United States
facility: Clayton Medical Associates
state: Missouri
city: St. Louis
country: United States
facility: St. John's Mercy Health System
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Berlin
country: United States
facility: CCR Trials
state: New Jersey
city: Cherry Hill
country: United States
facility: School of Osteopathic Medicine
state: New Jersey
city: Edison
country: United States
facility: Anderson & Collins Clinical Research, Inc.
state: New Jersey
city: Albany
country: United States
facility: Upstate Clinical Research, LLC
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Westfield
country: United States
facility: Great Lakes Medical Research
state: New York
city: Charlotte
country: United States
facility: Carolina Bone and Joint
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Research
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Mogadore
country: United States
facility: Radiant Research
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Clinical Research, LLC
state: Oklahoma
city: Eugene
country: United States
facility: PRO Research
state: Oregon
city: Medford
country: United States
facility: Medford Medical Clinic, LLP
state: Oregon
city: Mechanicsburg
country: United States
facility: Central Pennsylvania Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Charleston
country: United States
facility: Low Country Research Center
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Greer
state: South Carolina
city: Chattanooga
country: United States
facility: Clinsearch
state: Tennessee
city: Knoxville
country: United States
facility: Rheumatology Consultants, PLLC
state: Tennessee
city: Austin
country: United States
facility: Walter M. Chase, MD
state: Texas
city: Austin
country: United States
facility: Future Search Trials of Neurology Future Research Trials
state: Texas
city: Fort Worth
country: United States
facility: DFW Wellness
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Systems
state: Texas
city: Houston
country: United States
facility: Houston Sleep Center
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: Fatigue Consultation Center
state: Utah
city: Kirkland
country: United States
facility: Richard A. Neiman, MD, Inc.
state: Washington
city: Renton
country: United States
facility: Pacific Rheumatolgy Associates, Inc.
state: Washington
city: Charleston
country: United States
facility: Charrleston Internal Medicine
state: West Virginia
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: I. Jon Russell, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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. 2009 Jan;60(1):299-309. doi: 10.1002/art.24142.
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):815.
citation: 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.