A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.


Brief Summary

The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

Intervention / Treatment

  • Placebo (DRUG)
    Oral Solution
  • Xyrem® (DRUG)
    two doses

Condition or Disease

  • Fibromyalgia


  • Phase 3
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 573 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Treatment


    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2006
    Primary Completion: Apr 01, 2009 ACTUAL
    Completion Date: Jun 01, 2009 ACTUAL
    Study First Posted: Jan 18, 2007 ESTIMATED
    Results First Posted: Jan 10, 2012 ESTIMATED
    Last Updated: Jan 20, 2012

    Sponsors / Collaborators

    Lead Sponsor: Jazz Pharmaceuticals
    Lead sponsor is responsible party
    Responsible Party: N/A


    The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-two (22) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) will be allowed.

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.

    Exclusion Criteria:

    * Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms.
    * Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.

    Primary Outcomes
    • Percentage of pain VAS responders. Subjects with a \>= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.

    More Details

    NCT Number: NCT00423813
    Other IDs: 06-009
    Study URL: https://clinicaltrials.gov/study/NCT00423813
    Last updated: Sep 29, 2023