A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
1 other identifier
interventional
573
8 countries
116
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 Dec 2006
116 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
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 16, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
January 10, 2012
CompletedJanuary 24, 2012
December 1, 2011
2.3 years
January 16, 2007
September 8, 2011
January 20, 2012
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 (116)
East Alabama Arthritis Center
Auburn, Alabama, 36830, United States
Capstone Clinical Trials, Inc.
Birmingham, Alabama, 35209, United States
Drug Research and Analysis Corporation
Montgomery, Alabama, 36106, United States
dba 21st Century Neurology
Phoenix, Arizona, 85004, United States
Orange County Clinical Trials
Anaheim, California, 92801, United States
Providence Clinical Research
Burbank, California, 91505, United States
Med Investigations, Inc.
Fair Oaks, California, 95628, United States
North Orange County Research Institute, Inc.
Fullerton, California, 92835, United States
Nerve Pro Research
Irvine, California, 92618, United States
Northridge Neurological Center
Northridge, California, 91325, United States
Arroyo Medical Group
Pismo Beach, California, 93449, United States
Northern California Research
Sacramento, California, 95821, United States
Sacramento Research Medical Group
Sacramento, California, 95825, United States
University of CT, Health Center
Farmington, Connecticut, 06030-1310, United States
Center for Musculoskeletal Pain Research
Gainesville, Florida, 32610, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Suncoast Internal Medicine Consultants
Largo, Florida, 33773, United States
AppleMed Research
Miami, Florida, 33155, United States
Compass Research
Orlando, Florida, 32806, United States
Clinical Research Group of St. Petersburg, Inc.
St. Petersburg, Florida, 33707, United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614, United States
Lake Rheumatology
Tavares, Florida, 32778, United States
Center for Arthritis and Rheumatism
Vero Beach, Florida, 32962, United States
Florida Medical Clinic, P.A., Clinical Research Division
Zephyrhills, Florida, 33542, United States
Drug Studies America
Marietta, Georgia, 30066, United States
Coeur d'Alene Arthritis Clinic
Coeur d'Alene, Idaho, 83814, United States
Fibromyalgia Treatment Centers of America
Chicago, Illinois, 60641, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46254, United States
Cotton-O'neil Clinical Research center
Topeka, Kansas, 66606, United States
Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky, 42701, United States
Central Kentucky Research Associates,Inc.
Lexington, Kentucky, 40509, United States
Bluegrass Internal Medicine
Owensboro, Kentucky, 42303, United States
Louisiana Sleep Foundation
Baton Rouge, Louisiana, 70809, United States
Capital Clinical Research Associates
Rockville, Maryland, 20852, United States
Professional Clinical Research at Cyrstal Lake Health Center
Benzonia, Michigan, 49616, United States
Quest Research Institute
Bingham Farms, Michigan, 48025, United States
Professional Clinical Research
Cadillac, Michigan, 49601, United States
Professional Clinical Research at Crystal Lake Health Center
Interlochen, Michigan, 49643, United States
Arthritis Associates
Hattiesburg, Mississippi, 39402, United States
Medex Healthcare Research, Inc
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
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Alan Lichtbroun, MD
East Brunswick, New Jersey, 08816, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, United States
North Shore University Hospital, North Shore Pain Services
Valley Stream, New York, 11580, United States
Great Lakes Medical Research
Westfield, New York, 14787, United States
Appalachian Regional Medical Associates
Boone, North Carolina, 28607-0000, United States
Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU
Greenville, North Carolina, 27834, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
Health Research Associates, LLC (HRA)
Cleveland, Ohio, 44121, United States
Ohio State U, Immunology/Rheumatology William Davis Medical Research Center
Columbus, Ohio, 43210, United States
Cleveland Neuro-Sleep Research Institute Inc.
Middleburg Heights, Ohio, 44130, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210, United States
Oregon Health Sciences University School of Medicine
Portland, Oregon, 97239, United States
Tri State Medical Group, Inc.
Beaver, Pennsylvania, 15009, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Founders Research
Yardley, Pennsylvania, 19067, United States
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, 29204, United States
Neurology Future Research Trials
Austin, Texas, 78756, United States
DFW Wellness
Fort Worth, Texas, 76108, United States
The Methodist Hospital System
Houston, Texas, 77030, United States
Houston Sleep Center
Houston, Texas, 77063, United States
R/D Clinical Research, Inc.
Houston, Texas, 77074, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Arthritis & Osteoporosis Center of South Texas
San Antonio, Texas, 78232, United States
Clinical Health Research, LLC
Sugarland, Texas, 77479, United States
Arthritis and Osteoporosis Clinic, Research Center of Central Texas
Waco, Texas, 76708, United States
Alben Goldstein, MD, FACP
Arlington, Virginia, 22204, United States
Rhumatologie
Amiens, France
CHU de Grenoble-hopital Sud
Échirolles, France
Hopital Claude Huriez Service de medecine Interne
Lille, France
Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord
Nantes, France
Hopital Pasteue - Pavillon O
Nice, France
Hopital Hotel Dieu service de medecine interne
Paris, France
CHU Hopital de Rangueil
Toulouse, France
Schlosspark-Klinik
Berlin, Germany
Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie
Böblingen, Germany
Intensivmedizin der Uniklinik Koln
Cologne, Germany
Praxis Dr. Wiedeking
Essen, Germany
Praxis fur Innere Medizin und Rheumatologie
Gräfelfing, Germany
Gemeinschaftspraxis Schmerzzentrum
Hamburg, Germany
Rheumazentrum am Krankenhaus Bad Doberan
Hohenfelde - Bad Doberan, Germany
Praxisklinik Dr. Weiss
Mannheim, Germany
Praxis Dr. Sohn
Schwalmtal, Germany
Azienda Ospedaliera Luigi Sacco
Milan, Italy
Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara
Pisa, Italy
Amphia Ziekenhuis
Breda, Netherlands
Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis
Enschede, Netherlands
Wojewodzki Szpital Zespolony
Elblag, Poland
Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny
Katowice, Poland
Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny
Poznan, Poland
w Szczecinie
Szczecinie, Poland
NZOZ Nasz Lekarz
Torun, Poland
Instytut Reumatologii
Warsaw, Poland
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Instituto Ferran de Reumatologia
Barcelona, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Spain
Hospital Civil de malaga
Málaga, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain
Barnsley District General Hospital, Rheumatology Department
Barnsley, S75 2EP, United Kingdom
Royal National Hospital for Rheumatic Diseases NHS
Bath, BA1 1RL, United Kingdom
Lever Chambers Centre for Health
Bolton, United Kingdom
King's College London
London, SE5 9RJ, United Kingdom
4 West Kennedy Clinical Trial unit
London, United Kingdom
King College London
London, United Kingdom
Freeman Hospital
Newcastle, NE7 7DN, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Philip Arnold Unit
Poole, BH15 2JB, United Kingdom
Poole General Hospital
Poole, United Kingdom
Related Publications (7)
Bennett RM, Benson B, Choy EH, Hackshaw KV, Alvarez-Horine S, Wang, YG, Spaeth M. Effects of Sodium Oxybate on Pain, Function, and PGIC in Fibromyalgia: Results From an International, 14-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial. [AAPM abstract 186]. Pain Med. 2010;11(2):317.
RESULTSwick TJ, Spaeth M, Choy EH, Alvarez-Horine S, Wang YG, Benson B, Bennett R. Sodium Oxybate Reduces Pain and Improves Function and PGIC in Fibromyalgia: Results From an International, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial [AAN abstract P03.293]. Neurology. 2010;74(suppl 2):A280.
RESULTBennett RM, Rosenthal N, Lai C, Benson B, Wang YG, Alegre C, Perrot S.. Functionality and Quality of Life Are Improved in Fibromyalgia Patients Treated With Sodium Oxybate: Results From a Phase 3 International Trial. In: American Psychiatric Association New Research Abstracts to the 2010 Annual Meeting; May 22-26, 2010; New Orleans, LA. Abstract NR7-49.
RESULTSwick TJ, Curtis C, Benson B, Lai C, Wang YG, Rothman J, Sarzi-Puttini P. Fibromyalgia Patients Have Impaired Sleep and Daytime Functioning at Baseline: Data From an International Phase 3 Trial of Sodium Oxybate [APSS abstract 0882]. Sleep. 2010;33(suppl):A295.
RESULTSwick TJ, Lai C, Benson B, Wang YG, Sarzi-Puttini P. Fibromyalgia Pain, Fatigue, and Sleep Improve With Sodium Oxybate Treatment: A 14-Week Randomized, Double-Blind, Placebo-Controlled International Trial [APSS abstract 0883]. Sleep. 2010;33(suppl):A295.
RESULTChoy E, Alegre C, Sarzi-Puttini P, van Seventer R, Wang YG, Guinta D, Lai C, Bennett R and the Oxybate in Fibromyalgia 06-009 Study Group. The Effects of Sodium Oxybate on Sleep Disturbance, Fatigue, and Functioning in Fibromyalgia: Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled International Trial [FRI10411]. Ann Rheum Dis. 2010;69(suppl 3):449.
RESULTSpaeth M, Perrot S, Samborski W, Bazzichi L, van de Laar M, Guinta D, Wang YG, Lai C, Bennett R and Sodium Oxybate in Fibromyalgia 06-009 Study Group. Sodium Oxybate Treatment Improves Pain, Function, and Patient Global Impression of Change (PGIC) in Fibromyalgia Patients: Results From an International, Randomized, Double-Blind, Placebo-Controlled Trial. Ann Rheum Dis. 2010;69(suppl 3):449
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.
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
January 16, 2007
First Posted
January 18, 2007
Study Start
December 1, 2006
Primary Completion
April 1, 2009
Study Completion
June 1, 2009
Last Updated
January 24, 2012
Results First Posted
January 10, 2012
Record last verified: 2011-12