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

March 28, 2012 updated by: Jazz Pharmaceuticals

A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens Cedex 1, France
        • Rhumatologie
      • Echirolles Cedex, France
        • Chu de Grenoble-Hopital Sud
      • Lille Cedex, France
        • Hopital Claude Huriez Service de medecine Interne
      • Nantes cedex 2, France
        • Centre Catherine de Sienne unite d evaluation et de traitement de la douleur
      • Paris cedex 04, France
        • Hopital Hotel Dieu service de medicine interne
      • Toulouse Cedex 9, France
        • CHU Hopital de Rangueil
  • Germany
      • Boblingen, Germany
        • Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie
      • Essen, Germany
        • Praxis Dr. Wiedeking
      • Grafelfing, Germany
        • Praxis fur Innere Medizin und Rheumatologie
      • Hamburg, Germany
        • Gemeinschaftspraxis Schmerzzentrum
      • Koln, Germany
        • Intensivmedizin der Uniklinik Koln
      • Mannheim, Germany
        • Praxisklinik Dr. Weiss
      • Schwalmtal, Germany
        • Praxis Dr. Sohn
  • Italy
      • Pisa, Italy
        • Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara
  • Netherlands
      • Breda, Netherlands
        • Amphia Ziekenhuis
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Hospital Santa Creu i Snt Pau
      • Barcelona, Spain
        • Instituto Ferran de Reumatologia
      • Guadalajara, Spain
        • Hospital Universitario de Guadalajara
      • Malaga, Spain
        • Hospital Civil de Málaga
      • Oviedo, Spain
        • Hospital Central de Asturias
      • Santiago de Compostela, Spain
        • Hospital Clínico Universitario de Santiago
  • United Kingdom
      • Bolton, United Kingdom
        • Lever Chambers Centre for Health
      • London, United Kingdom
        • Kings College London
      • Newcastle upon Tyne, United Kingdom
        • Freeman Hospital
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
      • Auburn, Alabama, United States
        • Suncoast Internal Medicine Consultants
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Anaheim, California, United States
        • Orange County Clinical Trials
      • Carmichael, California, United States, 95608
        • Northern California Research
      • Fair Oaks, California, United States
        • Med Investigations Inc.
      • Irvine, California, United States
        • Nerve Pro Research
      • Pismo Beach, California, United States, 93449
        • Arroyo Medical Group, Inc.
    • Florida
      • Miami, Florida, United States
        • AppleMed Research
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Plantation, Florida, United States, 33317
        • Sunrise Medical Research
      • St. Petersburg, Florida, United States
        • Clinical Research Group of St. Petersburg, Inc
      • Tampa, Florida, United States
        • Tampa Medical Group, P.A.
      • Vero Beach, Florida, United States
        • Center for Arthiritis and Rheumatism
      • Zephyhills, Florida, United States
        • Florida Medical Clinic, P.A.
    • Georgia
      • Marietta, Georgia, United States
        • Drug Studies America
    • Idaho
      • Coeur d' Alene, Idaho, United States
        • Coeur d' Alene Arthritis Clinic
    • Illinois
      • Chicago, Illinois, United States
        • Fibromyalgia Treatment Centers of America
      • Gurnee, Illinois, United States, 60031
        • Deerpath Physcians Group
      • Peoria, Illinois, United States, 61614
        • Balanced Health Research Center
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves - Gilbert Clinic
      • Elizabethtown, Kentucky, United States
        • Center for Arthiritis & Osteoporosis
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates, Inc.
      • Madisonville, Kentucky, United States, 42431
        • Commonwealth Biomedical Research, LLC
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Louisiana Sleep Foundation
    • Maryland
      • Rockville, Maryland, United States
        • Capital Clinical Rsearch Asociates
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • FutureCare Studies
      • Worcester, Massachusetts, United States, 01610
        • Clinical Pharmacology Study Group
    • Michigan
      • Benzonia, Michigan, United States
        • Professional Clinical Research, Inc. at Crystal Lake Health Center
      • Cadillac, Michigan, United States
        • Professional Clinical Research
      • Interlocken, Michigan, United States, 49643
        • Professional Clinical Research at Crystal Lake Health Center
      • Lansing, Michigan, United States, 48917
        • PCM Medical Services
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • School of Osteopathic Medicine
      • Edison, New Jersey, United States, 08817
        • Anderson & Collins Clinical Research, Inc.
    • New York
      • Albany, New York, United States, 12205
        • Upstate Clinical Research, LLC
      • Rochester, New York, United States, 14618
        • AAIR Research Center
      • Valley Stream, New York, United States
        • North Shore University Hospital
    • North Carolina
      • Boone, North Carolina, United States
        • Appalachian Regional Medical Associates
      • Charlotte, North Carolina, United States, 28210
        • Carolina Bone and Joint
      • Durham, North Carolina, United States, 27103
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States
        • Hill Top Physicians Inc./Hightop Medical Research Center
      • Mogadore, Ohio, United States, 44260
        • Radiant Research
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Tulsa Clinical Research, LLC
    • Oregon
      • Eugene, Oregon, United States, 97401
        • PRO Research
      • Portland, Oregon, United States
        • School of Nursing
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Tri State Medical Group, Inc.
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Mechanicsburg, Pennsylvania, United States, 17055
        • Central Pennsylvania Clinical Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Research Country
      • Columbia, South Carolina, United States
        • Southern Orthopaedic Sports Medicine
      • Greer, South Carolina, United States, 29651
        • Radiant Research, Greer
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Rheumatology Consultants, PLLC
    • Texas
      • Austin, Texas, United States, 78705
        • Walter F. Chase, MD PA
      • Houston, Texas, United States, 77074
        • R/D Clinical Research, Inc.
      • San Antonio, Texas, United States, 78205
        • Sun Research Institute
      • San Antonio, Texas, United States, 78217
        • Radiant Research San Antonio Northeast
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Fatigue Consultation Center
    • Washington
      • Kirkland, Washington, United States, 98034
        • Evergreen Hospital Medical Center
      • Renton, Washington, United States, 98055
        • Pacific Rheumatology Associates, Inc.
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Xyrem®
flexible dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting Adverse Events
Time Frame: Treatment Period (38 weeks)
Number of subjects reporting adverse events.
Treatment Period (38 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 16, 2007

First Submitted That Met QC Criteria

January 16, 2007

First Posted (Estimate)

January 18, 2007

Study Record Updates

Last Update Posted (Estimate)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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