NCT00915135

Efficacy and Safety of Ramelteon on Chronic Insomnia

A Double-Blind, Dose-Response, Cross-Over Study of TAK-375 With Chronic Insomnia (Phase II Study) -- Polysomnographic Evaluation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia

Detailed description

Complaints of sleep disorder are increasing with today's aging society and changing lifestyle. Sleep disorders not only impact one's activities of daily living, but also impede one's social life, leading to reduced productivity and sometimes accidents through carelessness. 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.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	Ramelteon and Placebo (25 possible combinations total)	Randomized sequence over two consecutive nights for a total of five treatment periods to include the following: Ramelteon 4 mg, tablets, orally over two nights Ramelteon 8 mg, tablets, orally over two nights Ramelteon 16 mg, tablets, orally over two nights Ramelteon 32 mg, tablets, orally over two nights Ramelteon placebo-matching tablets, orally over two nights

Timeline

• Start date: 2002-05-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2009-06-05
• Last updated: 2010-06-02