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

Phase 3

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: Sodium Oxybate; Drug: Sodium Oxybate & 6 Tablets; Drug: Sodium Oxybate Oral Solution (6 grams); Drug: Sodium Oxybate & 8 Tablets

• Registration Number: NCT00803023
• Lead Sponsor: Jazz Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-05
• Study Start: 2010-03
• Primary Completion: 2010-07
• Results First Submitted: 2011-07-21
• Results First Submitted QC: 2011-07-21
• Status Verified: 2011-08
• Results First Posted: 2011-08-16
• Last Update Submitted: 2011-08-17
• Last Update Posted: 2011-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sodium Oxybate	Sodium Oxybate Oral Solution (4.5 grams)
2	Sodium Oxybate & 6 Tablets	Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams)
3	Sodium Oxybate Oral Solution (6 grams)	Sodium Oxybate Oral Solution (6 grams)
4	Sodium Oxybate & 8 Tablets	Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)

Primary Outcome Measures

Name	Time	Method
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects	4 weeks

Secondary Outcome Measures

Name	Time	Method
Tolerability Assessed by Adverse Events	4 weeks

Trial Locations

Locations (32)

Sun Research Institute; 🇺🇸 San Antonio, Texas, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Dba 21st Century Neurology; 🇺🇸 Phoenix, Arizona, United States

Quality Clinical Research, Inc; 🇺🇸 Omaha, Nebraska, United States

Clinsearch; 🇺🇸 Chattanooga, Tennessee, United States

The Center for Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Arroyo Medical Group, Inc.; 🇺🇸 Pismo Beach, California, United States

Clinical Physiology Associates Clinical Study; 🇺🇸 Fort Meyers, Florida, United States

Med Investigations, Inc.; 🇺🇸 Fair Oaks, California, United States

Orange County Clinical Trials; 🇺🇸 Anaheim, California, United States

Northridge Neurological Center; 🇺🇸 Northridge, California, United States

Northern California Research; 🇺🇸 Sacramento, California, United States

Graves Gilbert Clinic; 🇺🇸 Bowling Green, Kentucky, United States

Houston Sleep Clinic; 🇺🇸 Houston, Texas, United States

Hill Top Physicians Inc. / Hihgtop Medical Research Center; 🇺🇸 Cincinnati, Ohio, United States

Pacific Rheumatology Associates; 🇺🇸 Renton, Washington, United States

Southern Orthopeadic Sports; 🇺🇸 Columbia, South Carolina, United States

Clinical Health Research, LLC; 🇺🇸 Sugar Land, Texas, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Apex Research Institute; 🇺🇸 Santa Ana, California, United States

Memorial Medical Group - Clinical Research; 🇺🇸 South Bend, Indiana, United States

Commonwealth Biomedical Resaerch, LLC; 🇺🇸 Madisonville, Kentucky, United States

Compass Research; 🇺🇸 Orlando, Florida, United States

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Albuquerque Neuroscience, Inc.; 🇺🇸 Albuquerque, New Mexico, United States

Louisiana Sleep Foundation; 🇺🇸 Baton Rouge, Louisiana, United States

Professional clinical Research - Interlochen; 🇺🇸 Interlochen, Michigan, United States

The Carolina Center for Rheumatology & ArthiritisCare PA; 🇺🇸 Rock Hill, South Carolina, United States

FutureSearch Trials of Neurology; 🇺🇸 Austin, Texas, United States

Central Pennsylvania Clinic; 🇺🇸 Mechanicsburg, Pennsylvania, United States

DFW Wellness; 🇺🇸 Fort Worth, Texas, United States

Superior Research, LLC; 🇺🇸 Sacramento, California, United States