At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 75 enrolled
Drug / intervention
ramelteon +1 moredrug
Likely dose
Not stated in 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.
Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
In Brief
A Phase 4 clinical trial evaluating ramelteon and placebo for Insomnia. Completed, enrolled 75 participants.
Detailed Summary
The purpose of this study is to help scientist better understand the effect of a 12-week single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep or staying asleep). The study will measure levels of inflammation, fasting insulin and fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
Primary CompletionJun 2008
First PostedJun 2014
TodayJul 2026
First PostedJun 5, 2014
Enrollment StartJul 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.1 years ago
Interventions
ramelteondrug
placebodrug