A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.

NCT ID: NCT00423813

Last Updated: 2012-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 573 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-06-30

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Oral Solution

2

Group Type: EXPERIMENTAL

Xyrem®

Intervention Type: DRUG

two doses

Interventions

placebo

Oral Solution

Intervention Type: DRUG

Xyrem®

two doses

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

East Alabama Arthritis Center

Auburn, Alabama, United States

Capstone Clinical Trials, Inc.

Birmingham, Alabama, United States

Drug Research and Analysis Corporation

Montgomery, Alabama, United States

dba 21st Century Neurology

Phoenix, Arizona, United States

Orange County Clinical Trials

Anaheim, California, United States

Providence Clinical Research

Burbank, California, United States

Med Investigations, Inc.

Fair Oaks, California, United States

North Orange County Research Institute, Inc.

Fullerton, California, United States

Nerve Pro Research

Irvine, California, United States

Northridge Neurological Center

Northridge, California, United States

Arroyo Medical Group

Pismo Beach, California, United States

Northern California Research

Sacramento, California, United States

Sacramento Research Medical Group

Sacramento, California, United States

University of CT, Health Center

Farmington, Connecticut, United States

Center for Musculoskeletal Pain Research

Gainesville, Florida, United States

Florida Institute of Medical Research

Jacksonville, Florida, United States

Suncoast Internal Medicine Consultants

Largo, Florida, United States

AppleMed Research

Miami, Florida, United States

Compass Research

Orlando, Florida, United States

Clinical Research Group of St. Petersburg, Inc.

St. Petersburg, Florida, United States

Tampa Medical Group, P.A.

Tampa, Florida, United States

Lake Rheumatology

Tavares, Florida, United States

Center for Arthritis and Rheumatism

Vero Beach, Florida, United States

Florida Medical Clinic, P.A., Clinical Research Division

Zephyrhills, Florida, United States

Drug Studies America

Marietta, Georgia, United States

Coeur d'Alene Arthritis Clinic

Coeur d'Alene, Idaho, United States

Fibromyalgia Treatment Centers of America

Chicago, Illinois, United States

Investigative Clinical Research of Indiana, LLC

Indianapolis, Indiana, United States

Cotton-O'neil Clinical Research center

Topeka, Kansas, United States

Center for Arthritis and Osteoporosis

Elizabethtown, Kentucky, United States

Central Kentucky Research Associates,Inc.

Lexington, Kentucky, United States

Bluegrass Internal Medicine

Owensboro, Kentucky, United States

Louisiana Sleep Foundation

Baton Rouge, Louisiana, United States

Capital Clinical Research Associates

Rockville, Maryland, United States

Professional Clinical Research at Cyrstal Lake Health Center

Benzonia, Michigan, United States

Quest Research Institute

Bingham Farms, Michigan, United States

Professional Clinical Research

Cadillac, Michigan, United States

Professional Clinical Research at Crystal Lake Health Center

Interlochen, Michigan, United States

Arthritis Associates

Hattiesburg, Mississippi, United States

Medex Healthcare Research, Inc

St Louis, Missouri, United States

St. John's Mercy Health System

St Louis, Missouri, United States

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Comprehensive Clinical Research

Berlin, New Jersey, United States

Alan Lichtbroun, MD

East Brunswick, New Jersey, United States

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, United States

North Shore University Hospital, North Shore Pain Services

Valley Stream, New York, United States

Great Lakes Medical Research

Westfield, New York, United States

Appalachian Regional Medical Associates

Boone, North Carolina, United States

Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU

Greenville, North Carolina, United States

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Hightop Medical Research Center

Cincinnati, Ohio, United States

Health Research Associates, LLC (HRA)

Cleveland, Ohio, United States

Ohio State U, Immunology/Rheumatology William Davis Medical Research Center

Columbus, Ohio, United States

Cleveland Neuro-Sleep Research Institute Inc.

Middleburg Heights, Ohio, United States

Summit Research Network (Oregon) Inc.

Portland, Oregon, United States

Oregon Health Sciences University School of Medicine

Portland, Oregon, United States

Tri State Medical Group, Inc.

Beaver, Pennsylvania, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Founders Research

Yardley, Pennsylvania, United States

Southern Orthopaedic Sports Medicine

Columbia, South Carolina, United States

Neurology Future Research Trials

Austin, Texas, United States

DFW Wellness

Fort Worth, Texas, United States

The Methodist Hospital System

Houston, Texas, United States

Houston Sleep Center

Houston, Texas, United States

R/D Clinical Research, Inc.

Houston, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

University of Texas Health Science Center

San Antonio, Texas, United States

Arthritis & Osteoporosis Center of South Texas

San Antonio, Texas, United States

Clinical Health Research, LLC

Sugarland, Texas, United States

Arthritis and Osteoporosis Clinic, Research Center of Central Texas

Waco, Texas, United States

Alben Goldstein, MD, FACP

Arlington, Virginia, 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

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, , United Kingdom

Royal National Hospital for Rheumatic Diseases NHS

Bath, , United Kingdom

Lever Chambers Centre for Health

Bolton, , United Kingdom

King's College London

London, , United Kingdom

4 West Kennedy Clinical Trial unit

London, , United Kingdom

King College London

London, , United Kingdom

Freeman Hospital

Newcastle, , United Kingdom

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Philip Arnold Unit

Poole, , United Kingdom

Poole General Hospital

Poole, , United Kingdom

Countries

United States; France; Germany; Italy; Netherlands; Poland; Spain; United Kingdom

References

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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

Reference Type: RESULT

Other Identifiers

06-009

Identifier Type: -

Identifier Source: org_study_id