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

Completed · Phase 3 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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).

Key facts

Study ID

NCT00803023

Run by

Jazz Pharmaceuticals

People needed

129

Starts

2010-03-01

Last updated by the study team

2011-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dba 21st Century Neurology — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Orange County Clinical Trials — Anaheim, California, United States
• Med Investigations, Inc. — Fair Oaks, California, United States
• Northridge Neurological Center — Northridge, California, United States
• Arroyo Medical Group, Inc. — Pismo Beach, California, United States
• Northern California Research — Sacramento, California, United States
• Superior Research, LLC — Sacramento, California, United States
• Apex Research Institute — Santa Ana, California, United States
• Clinical Physiology Associates Clinical Study — Fort Meyers, Florida, United States
• Compass Research — Orlando, Florida, United States
• Memorial Medical Group - Clinical Research — South Bend, Indiana, United States
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States
• Commonwealth Biomedical Resaerch, LLC — Madisonville, Kentucky, United States
• Louisiana Sleep Foundation — Baton Rouge, Louisiana, United States
• Professional clinical Research - Interlochen — Interlochen, Michigan, United States
• Quality Clinical Research, Inc — Omaha, Nebraska, United States
• Albuquerque Neuroscience, Inc. — Albuquerque, New Mexico, United States
• The Center for Clinical Research — Winston-Salem, North Carolina, United States
• Hill Top Physicians Inc. / Hihgtop Medical Research Center — Cincinnati, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Central Pennsylvania Clinic — Mechanicsburg, Pennsylvania, United States
• Southern Orthopeadic Sports — Columbia, South Carolina, United States
• The Carolina Center for Rheumatology & ArthiritisCare PA — Rock Hill, South Carolina, United States

Full record on ClinicalTrials.gov

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