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
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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
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Sodium Oxybate & 8 Tablets (DRUG)6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night
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Sodium Oxybate Oral Solution (6 grams) (DRUG)6 grams per night taken in two equally divided doses
Condition or Disease
- Fibromyalgia
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| 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 |
Masking |
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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
Location
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.
* 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
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Tolerability Assessed by Adverse Events 4 weeks
More Details
| NCT Number: | NCT00803023 |
|---|---|
| Other IDs: | 08-004 |
| Study URL: | https://clinicaltrials.gov/study/NCT00803023 |
Last updated: Sep 29, 2023