At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
Ramelteon and Placebo (9 possible combinations total)drug
Likely dose
Ramelteon and Placebo (9 possible combinations total) 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 Phase III, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Determine the Safety and Efficacy of TAK-375 in Elderly Subjects With Chronic Insomnia.
In Brief
A Phase 3 clinical trial evaluating Ramelteon and Placebo (9 possible combinations total) for Chronic Insomnia. Completed, enrolled 100 participants across 18 sites.
Detailed Summary
This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily (QD), in elderly subjects with chronic insomnia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Insomnia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2002
Primary CompletionJul 2003
First PostedMay 2008
TodayJul 2026
First PostedMay 5, 2008
Enrollment StartOct 1, 2002
Primary CompletionJul 1, 2003
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.2 years ago
Interventions
Ramelteon and Placebo (9 possible combinations total)drug
Randomized sequence over two consecutive nights for a total of three treatment periods to include the following: Ramelteon 4 mg, tablets, orally over two nights Ramelteon 8 mg, tablets, orally over two nights Ramelteon placebo-matching tablets, orally over two nights