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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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 205 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00313885
The ClinicalTrials.gov registry entry for NCT00313885 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00313885 reports 0 study locations.
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.
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