Clinical trial NCT00423813: A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: FMS
Fibro
pain
Body pain
tenderness
stiffness
muscular pain
joint pain
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 573
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-two (22) 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 a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) 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: Auburn
country: United States
facility: East Alabama Arthritis Center
state: Alabama
city: Birmingham
country: United States
facility: Capstone Clinical Trials, Inc.
state: Alabama
city: Montgomery
country: United States
facility: Drug Research and Analysis Corporation
state: Alabama
city: Phoenix
country: United States
facility: dba 21st Century Neurology
state: Arizona
city: Anaheim
country: United States
facility: Orange County Clinical Trials
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Fair Oaks
country: United States
facility: Med Investigations, Inc.
state: California
city: Fullerton
country: United States
facility: North Orange County Research Institute, Inc.
state: California
city: Irvine
country: United States
facility: Nerve Pro Research
state: California
city: Northridge
country: United States
facility: Northridge Neurological Center
state: California
city: Pismo Beach
country: United States
facility: Arroyo Medical Group
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Sacramento
country: United States
facility: Sacramento Research Medical Group
state: California
city: Farmington
country: United States
facility: University of CT, Health Center
state: Connecticut
city: Gainesville
country: United States
facility: Center for Musculoskeletal Pain Research
state: Florida
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Largo
country: United States
facility: Suncoast Internal Medicine Consultants
state: Florida
city: Miami
country: United States
facility: AppleMed Research
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: St. Petersburg
country: United States
facility: Clinical Research Group of St. Petersburg, Inc.
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, P.A.
state: Florida
city: Tavares
country: United States
facility: Lake Rheumatology
state: Florida
city: Vero Beach
country: United States
facility: Center for Arthritis and Rheumatism
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A., Clinical Research Division
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Coeur d'Alene
country: United States
facility: Coeur d'Alene Arthritis Clinic
state: Idaho
city: Chicago
country: United States
facility: Fibromyalgia Treatment Centers of America
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Topeka
country: United States
facility: Cotton-O'neil Clinical Research center
state: Kansas
city: Elizabethtown
country: United States
facility: Center for Arthritis and Osteoporosis
state: Kentucky
city: Lexington
country: United States
facility: Central Kentucky Research Associates,Inc.
state: Kentucky
city: Owensboro
country: United States
facility: Bluegrass Internal Medicine
state: Kentucky
city: Baton Rouge
country: United States
facility: Louisiana Sleep Foundation
state: Louisiana
city: Rockville
country: United States
facility: Capital Clinical Research Associates
state: Maryland
city: Benzonia
country: United States
facility: Professional Clinical Research at Cyrstal Lake Health Center
state: Michigan
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Cadillac
country: United States
facility: Professional Clinical Research
state: Michigan
city: Interlochen
country: United States
facility: Professional Clinical Research at Crystal Lake Health Center
state: Michigan
city: Hattiesburg
country: United States
facility: Arthritis Associates
state: Mississippi
city: St. louis
country: United States
facility: Medex Healthcare Research, Inc
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: Comprehensive Clinical Research
state: New Jersey
city: East Brunswick
country: United States
facility: Alan Lichtbroun, MD
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Valley Stream
country: United States
facility: North Shore University Hospital, North Shore Pain Services
state: New York
city: Westfield
country: United States
facility: Great Lakes Medical Research
state: New York
city: Boone
country: United States
facility: Appalachian Regional Medical Associates
state: North Carolina
city: Greenville
country: United States
facility: Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Cleveland
country: United States
facility: Health Research Associates, LLC (HRA)
state: Ohio
city: Columbus
country: United States
facility: Ohio State U, Immunology/Rheumatology William Davis Medical Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Cleveland Neuro-Sleep Research Institute Inc.
state: Ohio
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences University School of Medicine
state: Oregon
city: Beaver
country: United States
facility: Tri State Medical Group, Inc.
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Yardley
country: United States
facility: Founders Research
state: Pennsylvania
city: Columbia
country: United States
facility: Southern Orthopaedic Sports Medicine
state: South Carolina
city: Austin
country: United States
facility: 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 System
state: Texas
city: Houston
country: United States
facility: Houston Sleep Center
state: Texas
city: Houston
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: San Antonio
country: United States
facility: Arthritis & Osteoporosis Center of South Texas
state: Texas
city: Sugarland
country: United States
facility: Clinical Health Research, LLC
state: Texas
city: Waco
country: United States
facility: Arthritis and Osteoporosis Clinic, Research Center of Central Texas
state: Texas
city: Arlington
country: United States
facility: Alben Goldstein, MD, FACP
state: Virginia
city: Amiens Cedex 1
country: France
facility: Rhumatologie
city: Echirolles Cedex
country: France
facility: CHU de Grenoble-hopital Sud
city: Lille Cedex
country: France
facility: Hopital Claude Huriez Service de medecine Interne
city: Nantes Cedex 2
country: France
facility: Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord
city: Nice Cedex 1
country: France
facility: Hopital Pasteue - Pavillon O
city: Paris Cedex 04
country: France
facility: Hopital Hotel Dieu service de medecine interne
city: Toulouse Cedex 9
country: France
facility: CHU Hopital de Rangueil
city: Berlin
country: Germany
facility: Schlosspark-Klinik
city: Boblingen
country: Germany
facility: Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie
city: Essen
country: Germany
facility: Praxis Dr. Wiedeking
city: Grafelfing
country: Germany
facility: Praxis fur Innere Medizin und Rheumatologie
city: Hamburg
country: Germany
facility: Gemeinschaftspraxis Schmerzzentrum
city: Hohenfelde - Bad Doberan
country: Germany
facility: Rheumazentrum am Krankenhaus Bad Doberan
city: Koln
country: Germany
facility: Intensivmedizin der Uniklinik Koln
city: Mannheim
country: Germany
facility: Praxisklinik Dr. Weiss
city: Schwalmtal
country: Germany
facility: Praxis Dr. Sohn
city: Milano
country: Italy
facility: Azienda Ospedaliera Luigi Sacco
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Enschede
country: Netherlands
facility: Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony
city: Katowice
country: Poland
facility: Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny
city: Poznan
country: Poland
facility: Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny
city: Szczecinie
country: Poland
facility: w Szczecinie
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz
city: Warszawa
country: Poland
facility: Instytut Reumatologii
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Instituto Ferran de Reumatologia
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
city: Malaga
country: Spain
facility: Hospital Civil de malaga
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Barnsley
country: United Kingdom
facility: Barnsley District General Hospital, Rheumatology Department
city: Bath
country: United Kingdom
facility: Royal National Hospital for Rheumatic Diseases NHS
city: Bolton
country: United Kingdom
facility: Lever Chambers Centre for Health
city: London
country: United Kingdom
facility: King's College London
city: London
country: United Kingdom
facility: 4 West Kennedy Clinical Trial unit
city: London
country: United Kingdom
facility: King College London
city: Newcastle upon tyne
country: United Kingdom
facility: Freeman Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Poole
country: United Kingdom
facility: Philip Arnold Unit
city: Poole
country: United Kingdom
facility: Poole General Hospital
Study officials:
References:
citation: 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.
citation: Swick 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.
citation: Bennett 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.
citation: Swick 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.
citation: Swick 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.
citation: Choy 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.
citation: Spaeth 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