NCT00672724

Efficacy of Ramelteon in Adults With Chronic Insomnia

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Subjective Response to Treatment With Ramelteon in Adult Subjects With Chronic Insomnia by Utilizing an Interactive Voice Response System (IVRS) for Collecting Diary Data

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,081 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), in adults with chronic insomnia.

Detailed description

Insomnia is characterized by difficulties initiating and maintaining sleep, or complaints of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects. Ramelteon is under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders. This study is being conducted to assess the treatment effects of ramelteon in adults through the use of daily entry of information into an interactive voice response system. Study participation in this study is anticipated to be about 1 month.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	Ramelteon	Ramelteon 8 mg tablets, taken orally, once daily for up to 2 weeks.
DRUG	Placebo	Ramelteon placebo-matching tablets, taken orally, once daily for up to 2 weeks.

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2008-05-06
• Last updated: 2012-02-28

Locations

43 sites across 1 country: United States