Clinical trial
A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
NCT00423813 · Jazz Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT00423813 |
|---|---|
| Title | A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia. |
| Official title | A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia. |
| Lead sponsor | Jazz Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Fibromyalgia |
| Intervention type | Drug |
| Interventions | placebo, Xyrem® |
| Enrollment | 573 |
| Start date | Dec 1, 2006 |
| Primary completion | Apr 1, 2009 |
| Completion | Jun 1, 2009 |
| First posted | Jan 18, 2007 |
| Last update posted | Jan 24, 2012 |
| Countries | France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: