At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 405 enrolled
Drug / intervention
Ramelteon +2 moredrug
Likely dose
Ramelteon 8 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 Phase III, Randomized, Double-Blind Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of TAK-375 in Adults With Chronic Insomnia
In Brief
A Phase 3 clinical trial evaluating Ramelteon and Placebo for Chronic Insomnia. Completed, enrolled 405 participants across 25 sites.
Detailed Summary
The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Insomnia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2003
Primary CompletionSep 2003
First PostedMay 2008
TodayJul 2026
First PostedMay 5, 2008
Enrollment StartJan 1, 2003
Primary CompletionSep 1, 2003
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.2 years ago
Interventions
Ramelteondrug
Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.
Ramelteondrug
Ramelteon 16 mg, tablets, orally, once nightly for up to 5 weeks.
Placebodrug
Ramelteon placebo-matching tablets, orally, once nightly for up to 5 weeks.