Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 205 participants
Start Date 2004-04
Est. Completion 2005-06
Phase Phase 2

Sponsor

Sanofi

713 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.