Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00423605
First received: January 16, 2007
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Fibromyalgia
Drug: Xyrem®
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Resource links provided by NLM:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Number of Subjects Reporting Adverse Events [ Time Frame: Treatment Period (38 weeks) ] [ Designated as safety issue: Yes ]
    Number of subjects reporting adverse events.


Enrollment: 560
Study Start Date: December 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Xyrem®
flexible dosing

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423605

  Hide Study Locations
Locations
United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
Suncoast Internal Medicine Consultants
Auburn, Alabama, United States
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Orange County Clinical Trials
Anaheim, California, United States
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Northern California Research
Carmichael, California, United States, 95608
Med Investigations Inc.
Fair Oaks, California, United States
Nerve Pro Research
Irvine, California, United States
Arroyo Medical Group, Inc.
Pismo Beach, California, United States, 93449
United States, Florida
AppleMed Research
Miami, Florida, United States
Compass Research
Orlando, Florida, United States, 32806
Sunrise Medical Research
Plantation, Florida, United States, 33317
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
United States, Georgia
Drug Studies America
Marietta, Georgia, United States
United States, Idaho
Coeur d' Alene Arthritis Clinic
Coeur d' Alene, Idaho, United States
United States, Illinois
Fibromyalgia Treatment Centers of America
Chicago, Illinois, United States
Deerpath Physcians Group
Gurnee, Illinois, United States, 60031
Balanced Health Research Center
Peoria, Illinois, United States, 61614
United States, Kentucky
Graves - Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
Center for Arthiritis & Osteoporosis
Elizabethtown, Kentucky, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Louisiana Sleep Foundation
Baton Rouge, Louisiana, United States
United States, Maryland
Capital Clinical Rsearch Asociates
Rockville, Maryland, United States
United States, Massachusetts
FutureCare Studies
Springfield, Massachusetts, United States, 01103
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Michigan
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, 49643
PCM Medical Services
Lansing, Michigan, United States, 48917
United States, Missouri
Clinvest
Springfield, Missouri, United States, 65807
United States, New Jersey
School of Osteopathic Medicine
Cherry Hill, New Jersey, United States, 08002
Anderson & Collins Clinical Research, Inc.
Edison, New Jersey, United States, 08817
United States, New York
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
AAIR Research Center
Rochester, New York, United States, 14618
North Shore University Hospital
Valley Stream, New York, United States
United States, North Carolina
Appalachian Regional Medical Associates
Boone, North Carolina, United States
Carolina Bone and Joint
Charlotte, North Carolina, United States, 28210
Duke University Medical Center
Durham, North Carolina, United States, 27103
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Hill Top Physicians Inc./Hightop Medical Research Center
Cincinnati, Ohio, United States
Radiant Research
Mogadore, Ohio, United States, 44260
United States, Oklahoma
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States, 74104
United States, Oregon
PRO Research
Eugene, Oregon, United States, 97401
School of Nursing
Portland, Oregon, United States
United States, Pennsylvania
Tri State Medical Group, Inc.
Beaver, Pennsylvania, United States, 15009
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, United States, 17055
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Low Country Research Country
Charleston, South Carolina, United States, 29406
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, United States
Radiant Research, Greer
Greer, South Carolina, United States, 29651
United States, Tennessee
Rheumatology Consultants, PLLC
Knoxville, Tennessee, United States, 37909
United States, Texas
Walter F. Chase, MD PA
Austin, Texas, United States, 78705
R/D Clinical Research, Inc.
Houston, Texas, United States, 77074
Radiant Research San Antonio Northeast
San Antonio, Texas, United States, 78217
Sun Research Institute
San Antonio, Texas, United States, 78205
The University of Texas Health Science
San Antonio, Texas, United States, 78229
United States, Utah
Fatigue Consultation Center
Salt Lake City, Utah, United States, 84102
United States, Washington
Evergreen Hospital Medical Center
Kirkland, Washington, United States, 98034
Pacific Rheumatology Associates, Inc.
Renton, Washington, United States, 98055
United States, West Virginia
Charleston Internal Medicine
Charleston, West Virginia, United States, 25304
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 traitement de la douleur
Nantes cedex 2, France
Hopital Hotel Dieu service de medicine interne
Paris cedex 04, France
CHU Hopital de Rangueil
Toulouse Cedex 9, France
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
Intensivmedizin der Uniklinik Koln
Koln, Germany
Praxisklinik Dr. Weiss
Mannheim, Germany
Praxis Dr. Sohn
Schwalmtal, Germany
Italy
Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara
Pisa, Italy
Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Santa Creu i Snt Pau
Barcelona, Spain
Instituto Ferran de Reumatologia
Barcelona, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital Civil de Malaga
Malaga, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain
United Kingdom
Lever Chambers Centre for Health
Bolton, United Kingdom
Kings College London
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Sponsors and Collaborators
Jazz Pharmaceuticals
  More Information

Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00423605     History of Changes
Other Study ID Numbers: 06-010
Study First Received: January 16, 2007
Results First Received: September 12, 2011
Last Updated: March 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Jazz Pharmaceuticals:
FMS
Fibro
Pain
Body Pain
Tenderness
Joint pain
Stiffness
Muscular Pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sodium Oxybate
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014