Clinical trial NCT00423605: Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Official title: A Long-Term, Open-Label, 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
Joint pain
Stiffness
Muscular Pain
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

Detailed description: The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.

Eligibility criteria: Inclusion Criteria:

* Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
* Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.

Exclusion Criteria:

* Subject terminated early from either study 06-009 or 06-008.
* Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.
* Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.

Primary outcomes:
measure: Number of Subjects Reporting Adverse Events
timeFrame: Treatment Period (38 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Auburn
country: United States
facility: Suncoast Internal Medicine Consultants
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Anaheim
country: United States
facility: Orange County Clinical Trials
state: California
city: Carmichael
country: United States
facility: Northern California Research
state: California
city: Fair Oaks
country: United States
facility: Med Investigations Inc.
state: California
city: Irvine
country: United States
facility: Nerve Pro Research
state: California
city: Pismo Beach
country: United States
facility: Arroyo Medical Group, Inc.
state: California
city: Miami
country: United States
facility: AppleMed 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: 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: Vero Beach
country: United States
facility: Center for Arthiritis and Rheumatism
state: Florida
city: Zephyhills
country: United States
facility: Florida Medical Clinic, P.A.
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: Gurnee
country: United States
facility: Deerpath Physcians Group
state: Illinois
city: Peoria
country: United States
facility: Balanced Health Research Center
state: Illinois
city: Bowling Green
country: United States
facility: Graves - Gilbert Clinic
state: Kentucky
city: Elizabethtown
country: United States
facility: Center for Arthiritis & Osteoporosis
state: Kentucky
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Louisiana Sleep Foundation
state: Louisiana
city: Rockville
country: United States
facility: Capital Clinical Rsearch Asociates
state: Maryland
city: Springfield
country: United States
facility: FutureCare Studies
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Benzonia
country: United States
facility: Professional Clinical Research, Inc. at Crystal Lake Health Center
state: Michigan
city: Cadillac
country: United States
facility: Professional Clinical Research
state: Michigan
city: Interlocken
country: United States
facility: Professional Clinical Research at Crystal Lake Health Center
state: Michigan
city: Lansing
country: United States
facility: PCM Medical Services
state: Michigan
city: Springfield
country: United States
facility: Clinvest
state: Missouri
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: Valley Stream
country: United States
facility: North Shore University Hospital
state: New York
city: Boone
country: United States
facility: Appalachian Regional Medical Associates
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Bone and Joint
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: Cincinnati
country: United States
facility: Hill Top Physicians Inc./Hightop Medical Research Center
state: Ohio
city: Mogadore
country: United States
facility: Radiant Research
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Clinical Research, LLC
state: Oklahoma
city: Eugene
country: United States
facility: PRO Research
state: Oregon
city: Portland
country: United States
facility: School of Nursing
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: 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 Country
state: South Carolina
city: Columbia
country: United States
facility: Southern Orthopaedic Sports Medicine
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Greer
state: South Carolina
city: Knoxville
country: United States
facility: Rheumatology Consultants, PLLC
state: Tennessee
city: Austin
country: United States
facility: Walter F. Chase, MD PA
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: Radiant Research San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science
state: Texas
city: Salt Lake City
country: United States
facility: Fatigue Consultation Center
state: Utah
city: Kirkland
country: United States
facility: Evergreen Hospital Medical Center
state: Washington
city: Renton
country: United States
facility: Pacific Rheumatology Associates, Inc.
state: Washington
city: Charleston
country: United States
facility: Charleston Internal Medicine
state: West 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 traitement de la douleur
city: Paris cedex 04
country: France
facility: Hopital Hotel Dieu service de medicine interne
city: Toulouse Cedex 9
country: France
facility: CHU Hopital de Rangueil
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: 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: Pisa
country: Italy
facility: Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Snt 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: 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: Bolton
country: United Kingdom
facility: Lever Chambers Centre for Health
city: London
country: United Kingdom
facility: Kings College London
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
References:
citation: Spaeth M, Russell IJ, Perrot S, Alvarez-Horine S, Guinta D, Wang YG, Bennett R. Durability of Response in a 38-Week Open-Label Study of Sodium Oxybate in Patients With Fibromyalgia [ACR/ARHP abstract 2356]. Arthritis Rheum. 2010;62(suppl 10):97.
citation: Spaeth M, Alegre C, Perrot S, Wang Y, Guinta DR, Alvarez-Horine S, Russell I; Sodium Oxybate Fibromyalgia Study Group. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia. Arthritis Res Ther. 2013 Nov 11;15(6):R185. doi: 10.1186/ar4375.