Status:
COMPLETED
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
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00803023
Start Date
March 1 2010
Last Update
August 19 2011
Active Locations (32)
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1
Dba 21st Century Neurology
Phoenix, Arizona, United States, 85004
2
Arizona Research Center
Phoenix, Arizona, United States, 85023
3
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
4
Orange County Clinical Trials
Anaheim, California, United States, 92801