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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
560

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: Xyrem®
flexible dosing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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