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
Public ClinicalTrials.gov record NCT00803023. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00803023
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 129 participants
Conditions and interventions
Conditions
Interventions
- Sodium Oxybate Drug
- Sodium Oxybate & 6 Tablets Drug
- Sodium Oxybate & 8 Tablets Drug
- Sodium Oxybate Oral Solution (6 grams) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2010
- Primary completion
- Jun 30, 2010
- Completion
- Not listed
- Last update posted
- Aug 18, 2011
Started 2010
United States locations
- U.S. sites
- 32
- U.S. states
- 16
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dba 21st Century Neurology | Phoenix | Arizona | 85004 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Orange County Clinical Trials | Anaheim | California | 92801 | — |
| Med Investigations, Inc. | Fair Oaks | California | 95628 | — |
| Northridge Neurological Center | Northridge | California | 91325 | — |
| Arroyo Medical Group, Inc. | Pismo Beach | California | 93449 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Superior Research, LLC | Sacramento | California | 95825 | — |
| Apex Research Institute | Santa Ana | California | 92705 | — |
| Clinical Physiology Associates Clinical Study | Fort Meyers | Florida | 33916 | — |
| Compass Research | Orlando | Florida | 32806 | — |
| Memorial Medical Group - Clinical Research | South Bend | Indiana | 46601 | — |
| Graves Gilbert Clinic | Bowling Green | Kentucky | 42101 | — |
| Commonwealth Biomedical Resaerch, LLC | Madisonville | Kentucky | 42431 | — |
| Louisiana Sleep Foundation | Baton Rouge | Louisiana | 70809 | — |
| Professional clinical Research - Interlochen | Interlochen | Michigan | 49643 | — |
| Quality Clinical Research, Inc | Omaha | Nebraska | 68114 | — |
| Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | 87109 | — |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Hill Top Physicians Inc. / Hihgtop Medical Research Center | Cincinnati | Ohio | 45224 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Central Pennsylvania Clinic | Mechanicsburg | Pennsylvania | 17055 | — |
| Southern Orthopeadic Sports | Columbia | South Carolina | 29204 | — |
| The Carolina Center for Rheumatology & ArthiritisCare PA | Rock Hill | South Carolina | 29732 | — |
| Clinsearch | Chattanooga | Tennessee | 37421 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78756 | — |
| DFW Wellness | Fort Worth | Texas | 76108 | — |
| Houston Sleep Clinic | Houston | Texas | 77063 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Clinical Health Research, LLC | Sugar Land | Texas | 77479 | — |
| Pacific Rheumatology Associates | Renton | Washington | 98055 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00803023, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2011 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00803023 live on ClinicalTrials.gov.