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
1 other identifier
interventional
129
1 country
32
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedResults Posted
Study results publicly available
August 16, 2011
CompletedAugust 19, 2011
August 1, 2011
4 months
December 3, 2008
July 21, 2011
August 17, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
4 weeks
Secondary Outcomes (1)
Tolerability Assessed by Adverse Events
4 weeks
Study Arms (4)
1
EXPERIMENTALSodium Oxybate Oral Solution (4.5 grams)
2
EXPERIMENTALSodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams)
3
EXPERIMENTALSodium Oxybate Oral Solution (6 grams)
4
EXPERIMENTALSodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)
Interventions
4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night
6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Dba 21st Century Neurology
Phoenix, Arizona, 85004, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Orange County Clinical Trials
Anaheim, California, 92801, United States
Med Investigations, Inc.
Fair Oaks, California, 95628, United States
Northridge Neurological Center
Northridge, California, 91325, United States
Arroyo Medical Group, Inc.
Pismo Beach, California, 93449, United States
Northern California Research
Sacramento, California, 95821, United States
Superior Research, LLC
Sacramento, California, 95825, United States
Apex Research Institute
Santa Ana, California, 92705, United States
Clinical Physiology Associates Clinical Study
Fort Meyers, Florida, 33916, United States
Compass Research
Orlando, Florida, 32806, United States
Memorial Medical Group - Clinical Research
South Bend, Indiana, 46601, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Commonwealth Biomedical Resaerch, LLC
Madisonville, Kentucky, 42431, United States
Louisiana Sleep Foundation
Baton Rouge, Louisiana, 70809, United States
Professional clinical Research - Interlochen
Interlochen, Michigan, 49643, United States
Quality Clinical Research, Inc
Omaha, Nebraska, 68114, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Hill Top Physicians Inc. / Hihgtop Medical Research Center
Cincinnati, Ohio, 45224, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Central Pennsylvania Clinic
Mechanicsburg, Pennsylvania, 17055, United States
Southern Orthopeadic Sports
Columbia, South Carolina, 29204, United States
The Carolina Center for Rheumatology & ArthiritisCare PA
Rock Hill, South Carolina, 29732, United States
Clinsearch
Chattanooga, Tennessee, 37421, United States
FutureSearch Trials of Neurology
Austin, Texas, 78756, United States
DFW Wellness
Fort Worth, Texas, 76108, United States
Houston Sleep Clinic
Houston, Texas, 77063, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Clinical Health Research, LLC
Sugar Land, Texas, 77479, United States
Pacific Rheumatology Associates
Renton, Washington, 98055, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Development
- Organization
- Jazz Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Grace Wang, MD
Jazz Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 3, 2008
First Posted
December 5, 2008
Study Start
March 1, 2010
Primary Completion
July 1, 2010
Last Updated
August 19, 2011
Results First Posted
August 16, 2011
Record last verified: 2011-08