NCT00671294

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily (QD), in elderly subjects with chronic insomnia.

Detailed description

Insomnia is characterized by a complaint of difficulties initiating and maintaining sleep or of nonrestorative 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 a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders. Participation in this study is anticipated to be about 2 months.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	Ramelteon and Placebo (9 possible combinations total)	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

Timeline

• Start date: 2002-10-01
• Primary completion: 2003-07-01
• Completion: 2003-07-01
• First posted: 2008-05-05
• Last updated: 2012-02-28

Locations

18 sites across 1 country: United States