Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia


Brief Summary

To compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).

Intervention / Treatment

  • Sodium Oxybate (DRUG)
    4.5 grams per night taken in two equally divided doses
  • Sodium Oxybate & 6 Tablets (DRUG)
    4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night
  • Sodium Oxybate & 8 Tablets (DRUG)
    6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night
  • Sodium Oxybate Oral Solution (6 grams) (DRUG)
    6 grams per night taken in two equally divided doses

Condition or Disease

  • Fibromyalgia


Study Design

Status: Completed
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 129 (ACTUAL)
Funded by: Industry
Allocation: Randomized
Primary Purpose: Treatment


Clinical Trial Dates

Start date: Mar 01, 2010
Primary Completion: Jul 01, 2010 ACTUAL
Completion Date: Aug 30, 2020
Study First Posted: Dec 05, 2008 ESTIMATED
Results First Posted: Aug 16, 2011 ESTIMATED
Last Updated: Aug 17, 2011

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Eligibility Criteria

Sex: All
Minimum Age: 18
Healthy Volunteers: Yes

Inclusion Criteria:

* Subject is able to understand the written informed consent
* Subject is 18 years of age or older.
* Subject meets the ACR criteria for fibromyalgia
* Subject is willing to discontinue prohibited by the protocol
* Subject agrees to use only non-sedating over-the-counter (OTC)medication
* Subject is willing to abstain from the ingestion of alcohol for the duration of the trial.

Exclusion Criteria:

* Subject has protocol prohibited medical \& psychiatric conditions that would exclude subject
* Subject has a current or past history of a substance use disorder including alcohol abuse
* Subject has a clinically significant history of seizure disorder either past or present
* Female subject who is pregnant, nursing or lactating.
* Subject is diagnosed with sleep apnea
* Subject is unable to discontinue protocol prohibited medications
* Subject is experiencing fatigue and/or drowsiness/sedation in association with intake of allowed medications.
* Subject has taken any investigational drug within 5 half-lives of the investigational drug prior to signing the informed consent form.
* Subject has an allergic reaction to GHB or sodium oxybate or any of its constituents (e.g. malic acid).
* Subject is on a sodium-restricted diet.
* Subject has abnormal liver function test or other abnormal lab values
* Subject has an occupation that requires variable shift work or routine night shifts or cannot routinely spend at least 6 hours per night in bed.
* Subject has any other problems that, in the investigator's opinion, would preclude the subject's participation and completion of this trial or compromise reliable representation of subjective symptoms.
* Subject has been randomized into a previous Xyrem (sodium oxybate) clinical trial.

Primary Outcomes
  • Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects 4 weeks
Secondary Outcomes
  • Tolerability Assessed by Adverse Events 4 weeks

More Details

NCT Number: NCT00803023
Other IDs: 08-004
Study URL:
Last updated: Sep 29, 2023