drugset / Trial / NCT00671398

Efficacy of Ramelteon on Transient Insomnia in Healthy Adults

NCT00671398 ↗

Phase 3 Completed 289 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab.

Timeline

Start
2002-12
Primary completion
2003-05
Completion
2003-05

Outcome

Met primary endpoint

paper Ramelteon 8 mg treatment significantly reduced latency to persistent sleep compared with placebo (12.2 min vs. 19.7 min, P=0.004). PMID 18691937 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramelteon Unknown 8 mg Oral
Subject Ramelteon Unknown 16 mg Oral

Indications