drugset / Trial / NCT00313885

Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia

NCT00313885

Phase 2 Completed 205 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2004-04
Primary completion
2005-06
Completion
2005-06

Drugs

EvaluationDrugModalityDoseRoute
Subject eplivanserin Small molecule 1 mg Oral
Subject eplivanserin Small molecule 5 mg Oral

Indications