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

Fibromyalgia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423813
• Other study ID #: 06-009
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2007
• Last updated: January 20, 2012
• Start date: December 2006
• Est. completion date: June 2009

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 573
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• placebo
Oral Solution
• Xyrem®
two doses

Locations

Country	Name	City	State
France	Rhumatologie	Amiens Cedex 1
France	CHU de Grenoble-hopital Sud	Echirolles Cedex
France	Hopital Claude Huriez Service de medecine Interne	Lille Cedex
France	Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord	Nantes Cedex 2
France	Hopital Pasteue - Pavillon O	Nice Cedex 1
France	Hopital Hotel Dieu service de medecine interne	Paris Cedex 04
France	CHU Hopital de Rangueil	Toulouse Cedex 9
Germany	Schlosspark-Klinik	Berlin
Germany	Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie	Boblingen
Germany	Praxis Dr. Wiedeking	Essen
Germany	Praxis fur Innere Medizin und Rheumatologie	Grafelfing
Germany	Gemeinschaftspraxis Schmerzzentrum	Hamburg
Germany	Rheumazentrum am Krankenhaus Bad Doberan	Hohenfelde - Bad Doberan
Germany	Intensivmedizin der Uniklinik Koln	Koln
Germany	Praxisklinik Dr. Weiss	Mannheim
Germany	Praxis Dr. Sohn	Schwalmtal
Italy	Azienda Ospedaliera Luigi Sacco	Milano
Italy	Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara	Pisa
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis	Enschede
Poland	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	Warszawa
Spain	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 Canarias	La Laguna
Spain	Hospital Universitario de Gran Canaria Dr. Negrin	Las Palmas de Gran Canaria
Spain	Hospital Civil de malaga	Malaga
Spain	Hospital Central de Asturias	Oviedo
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela
United Kingdom	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	4 West Kennedy Clinical Trial unit	London
United Kingdom	King College London	London
United Kingdom	King's 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 States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	Orange County Clinical Trials	Anaheim	California
United States	Alben Goldstein, MD, FACP	Arlington	Virginia
United States	East Alabama Arthritis Center	Auburn	Alabama
United States	Neurology Future Research Trials	Austin	Texas
United States	Louisiana Sleep Foundation	Baton Rouge	Louisiana
United States	Tri State Medical Group, Inc.	Beaver	Pennsylvania
United States	Professional Clinical Research at Cyrstal Lake Health Center	Benzonia	Michigan
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Quest Research Institute	Bingham Farms	Michigan
United States	Capstone Clinical Trials, Inc.	Birmingham	Alabama
United States	Appalachian Regional Medical Associates	Boone	North Carolina
United States	Providence Clinical Research	Burbank	California
United States	Professional Clinical Research	Cadillac	Michigan
United States	Fibromyalgia Treatment Centers of America	Chicago	Illinois
United States	Hightop Medical Research Center	Cincinnati	Ohio
United States	Health Research Associates, LLC (HRA)	Cleveland	Ohio
United States	Coeur d'Alene Arthritis Clinic	Coeur d'Alene	Idaho
United States	Southern Orthopaedic Sports Medicine	Columbia	South Carolina
United States	Ohio State U, Immunology/Rheumatology William Davis Medical Research Center	Columbus	Ohio
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Alan Lichtbroun, MD	East Brunswick	New Jersey
United States	Center for Arthritis and Osteoporosis	Elizabethtown	Kentucky
United States	Med Investigations, Inc.	Fair Oaks	California
United States	University of CT, Health Center	Farmington	Connecticut
United States	DFW Wellness	Fort Worth	Texas
United States	North Orange County Research Institute, Inc.	Fullerton	California
United States	Center for Musculoskeletal Pain Research	Gainesville	Florida
United States	Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU	Greenville	North Carolina
United States	Arthritis Associates	Hattiesburg	Mississippi
United States	Houston Sleep Center	Houston	Texas
United States	R/D Clinical Research, Inc.	Houston	Texas
United States	The Methodist Hospital System	Houston	Texas
United States	Investigative Clinical Research of Indiana, LLC	Indianapolis	Indiana
United States	Professional Clinical Research at Crystal Lake Health Center	Interlochen	Michigan
United States	Nerve Pro Research	Irvine	California
United States	Florida Institute of Medical Research	Jacksonville	Florida
United States	Suncoast Internal Medicine Consultants	Largo	Florida
United States	Central Kentucky Research Associates,Inc.	Lexington	Kentucky
United States	Drug Studies America	Marietta	Georgia
United States	AppleMed Research	Miami	Florida
United States	Cleveland Neuro-Sleep Research Institute Inc.	Middleburg Heights	Ohio
United States	Drug Research and Analysis Corporation	Montgomery	Alabama
United States	Northridge Neurological Center	Northridge	California
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Compass Research	Orlando	Florida
United States	Bluegrass Internal Medicine	Owensboro	Kentucky
United States	dba 21st Century Neurology	Phoenix	Arizona
United States	Arroyo Medical Group	Pismo Beach	California
United States	Oregon Health Sciences University School of Medicine	Portland	Oregon
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	Capital Clinical Research Associates	Rockville	Maryland
United States	Northern California Research	Sacramento	California
United States	Sacramento Research Medical Group	Sacramento	California
United States	Arthritis & Osteoporosis Center of South Texas	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	University of Texas Health Science Center	San Antonio	Texas
United States	Medex Healthcare Research, Inc	St. louis	Missouri
United States	St. John's Mercy Health System	St. Louis	Missouri
United States	Clinical Research Group of St. Petersburg, Inc.	St. Petersburg	Florida
United States	Clinical Health Research, LLC	Sugarland	Texas
United States	Tampa Medical Group, P.A.	Tampa	Florida
United States	Lake Rheumatology	Tavares	Florida
United States	Cotton-O'neil Clinical Research center	Topeka	Kansas
United States	North Shore University Hospital, North Shore Pain Services	Valley Stream	New York
United States	Center for Arthritis and Rheumatism	Vero Beach	Florida
United States	Arthritis and Osteoporosis Clinic, Research Center of Central Texas	Waco	Texas
United States	Great Lakes Medical Research	Westfield	New York
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	Founders Research	Yardley	Pennsylvania
United States	Florida Medical Clinic, P.A., Clinical Research Division	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

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

References & 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. [

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 N

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

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 Fibr

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)

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.

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 abstra

Outcome

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