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
NCT ID: NCT00803023
Last Updated: 2011-08-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
129 participants
INTERVENTIONAL
2010-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
NCT00423813
Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
NCT00087555
The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.
NCT00464737
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
NCT00423605
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
NCT02015234
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Sodium Oxybate Oral Solution (4.5 grams)
Sodium Oxybate
4.5 grams per night taken in two equally divided doses
2
Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams)
Sodium Oxybate & 6 Tablets
4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night
3
Sodium Oxybate Oral Solution (6 grams)
Sodium Oxybate Oral Solution (6 grams)
6 grams per night taken in two equally divided doses
4
Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)
Sodium Oxybate & 8 Tablets
6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sodium Oxybate
4.5 grams per night taken in two equally divided doses
Sodium Oxybate & 6 Tablets
4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night
Sodium Oxybate & 8 Tablets
6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night
Sodium Oxybate Oral Solution (6 grams)
6 grams per night taken in two equally divided doses
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jazz Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Grace Wang, MD
Role: STUDY_DIRECTOR
Jazz Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Clinsearch
Chattanooga, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
DFW Wellness
Fort Worth, Texas, United States
Houston Sleep Clinic
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Clinical Health Research, LLC
Sugar Land, Texas, United States
Pacific Rheumatology Associates
Renton, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
08-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.