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NCT00313885 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 205
- Enrollment target
NCT00313885: Completed Phase 2 study, sponsored by Sanofi.
NCT00313885 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 205 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00313885, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 205 participants
- Enrollment target
Study Summary
Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances are associated in patients with fibromyalgia. By improving the quality of sleep, complaints of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this chronic pain disorder may be improved.
Interventions
- DRUG placebo
- DRUG eplivanserin (SR46349)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2004-04 |
| Est. Completion | 2005-06 |
| Phase | Phase 2 |
What the finished NCT00313885 record still lists
NCT00313885 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00313885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00313885 about?
NCT00313885 is a clinical study titled "Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia". Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances are associated in patients with fibromyalgia. By improving the quality of sleep, complaints of poor and unrefreshing slee...
What is the current status of trial NCT00313885?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2004-04. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00313885?
The interventions under investigation include: placebo (DRUG), eplivanserin (SR46349) (DRUG).
Who is sponsoring clinical trial NCT00313885?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00313885's enrollment target sits among peer trials
205 298th of 2000 higher than 1,702 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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