At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 259 enrolled
Drug / intervention
Ramelteon +1 moredrug
Likely dose
Ramelteon 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Polysomnography Plus Outpatient Study to Determine the Safety and Efficacy of 4 mg Ramelteon in Adults With Chronic Insomnia
In Brief
A Phase 3 clinical trial evaluating Ramelteon and Placebo for Sleep Initiation and Maintenance Disorders. Completed, enrolled 259 participants.
Detailed Summary
The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once daily (QD), in subjects with chronic insomnia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
Primary CompletionMar 2008
First PostedSep 2008
TodayJul 2026
First PostedSep 19, 2008
Enrollment StartAug 1, 2007
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.8 years ago
Interventions
Ramelteondrug
Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.
Placebodrug
Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks.