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
Information source: Jazz Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia
Intervention: Sodium Oxybate (Drug); Sodium Oxybate & Tablet (Drug); Sodium Oxybate & Tablets (Drug); Sodium Oxybate Oral Solution (6 grams) (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Jazz Pharmaceuticals Official(s) and/or principal investigator(s):
Yanping Zheng, MD, Study Director, Affiliation: Jazz Pharmaceuticals
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).
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Single Blind (Subject), Single Group Assignment, Safety Study
Primary outcome: Safety as assessed by adverse events
Secondary outcome: Tolerability assessed by adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Advanced Clinical Research Institute, Anaheim, California 92801, United States
Additional Information
Starting date: December 2008
Last updated: December 3, 2008
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