Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
NCT ID: NCT00423605
Last Updated: 2012-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
560 participants
INTERVENTIONAL
2006-12-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Xyrem®
flexible dosing
Interventions
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Xyrem®
flexible dosing
Eligibility Criteria
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Inclusion Criteria
* Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Suncoast Internal Medicine Consultants
Auburn, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Orange County Clinical Trials
Anaheim, California, United States
Northern California Research
Carmichael, California, United States
Med Investigations Inc.
Fair Oaks, California, United States
Nerve Pro Research
Irvine, California, United States
Arroyo Medical Group, Inc.
Pismo Beach, California, United States
AppleMed Research
Miami, Florida, United States
Compass Research
Orlando, Florida, United States
Sunrise Medical Research
Plantation, Florida, United States
Clinical Research Group of St. Petersburg, Inc
St. Petersburg, Florida, United States
Tampa Medical Group, P.A.
Tampa, Florida, United States
Center for Arthiritis and Rheumatism
Vero Beach, Florida, United States
Florida Medical Clinic, P.A.
Zephyhills, 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
Deerpath Physcians Group
Gurnee, Illinois, United States
Balanced Health Research Center
Peoria, Illinois, United States
Graves - Gilbert Clinic
Bowling Green, Kentucky, United States
Center for Arthiritis & Osteoporosis
Elizabethtown, Kentucky, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
Louisiana Sleep Foundation
Baton Rouge, Louisiana, United States
Capital Clinical Rsearch Asociates
Rockville, Maryland, United States
FutureCare Studies
Springfield, Massachusetts, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Professional Clinical Research, Inc. at Crystal Lake Health Center
Benzonia, Michigan, United States
Professional Clinical Research
Cadillac, Michigan, United States
Professional Clinical Research at Crystal Lake Health Center
Interlocken, Michigan, United States
PCM Medical Services
Lansing, Michigan, United States
Clinvest
Springfield, Missouri, United States
School of Osteopathic Medicine
Cherry Hill, New Jersey, United States
Anderson & Collins Clinical Research, Inc.
Edison, New Jersey, United States
Upstate Clinical Research, LLC
Albany, New York, United States
AAIR Research Center
Rochester, New York, United States
North Shore University Hospital
Valley Stream, New York, United States
Appalachian Regional Medical Associates
Boone, North Carolina, United States
Carolina Bone and Joint
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Hill Top Physicians Inc./Hightop Medical Research Center
Cincinnati, Ohio, United States
Radiant Research
Mogadore, Ohio, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States
PRO Research
Eugene, Oregon, United States
School of Nursing
Portland, Oregon, United States
Tri State Medical Group, Inc.
Beaver, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Low Country Research Country
Charleston, South Carolina, United States
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, United States
Radiant Research, Greer
Greer, South Carolina, United States
Rheumatology Consultants, PLLC
Knoxville, Tennessee, United States
Walter F. Chase, MD PA
Austin, Texas, United States
R/D Clinical Research, Inc.
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, United States
The University of Texas Health Science
San Antonio, Texas, United States
Fatigue Consultation Center
Salt Lake City, Utah, United States
Evergreen Hospital Medical Center
Kirkland, Washington, United States
Pacific Rheumatology Associates, Inc.
Renton, Washington, United States
Charleston Internal Medicine
Charleston, West 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 traitement de la douleur
Nantes, , France
Hopital Hotel Dieu service de medicine interne
Paris, , France
CHU Hopital de Rangueil
Toulouse, , 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
Praxisklinik Dr. Weiss
Mannheim, , Germany
Praxis Dr. Sohn
Schwalmtal, , Germany
Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara
Pisa, , Italy
Amphia Ziekenhuis
Breda, , Netherlands
Hospital Santa Creu i Snt Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Instituto Ferran de Reumatologia
Barcelona, , Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Hospital Civil de Malaga
Málaga, , Spain
Hospital Central de Asturias
Oviedo, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Lever Chambers Centre for Health
Bolton, , United Kingdom
Kings College London
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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06-010
Identifier Type: -
Identifier Source: org_study_id
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