NCT00671125

Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

A Phase III, Randomized, Double-Blind Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of TAK-375 in Adults With Chronic Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep

Detailed description

Insomnia is characterized by 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 selective melatonin-1 receptor agonist 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 will determine the safety and efficacy of 35-day treatment of chronic insomnia with Ramelteon using polysomnography and subjective measures of sleep. Participation in this study is anticipated to be about 2 months.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	Ramelteon	Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.
DRUG	Ramelteon	Ramelteon 16 mg, tablets, orally, once nightly for up to 5 weeks.
DRUG	Placebo	Ramelteon placebo-matching tablets, orally, once nightly for up to 5 weeks.

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2008-05-05
• Last updated: 2012-11-12

Locations

25 sites across 1 country: United States