NCT00671567

Ramelteon in Adults With Chronic Insomnia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 848 (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 adult subjects with chronic insomnia.

Detailed description

Insomnia is characterized by difficulties initiating and maintaining sleep or complaints 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, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders. This study is designed to determine the safety and efficacy of 35-day treatment of chronic insomnia with Ramelteon, using subjective measures of sleep. Total subject participation time in this study is expected to be approximately 2 months.

Conditions

• Chronic Insomnia

Interventions

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

Timeline

• Start date: 2002-12-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2008-05-05
• Last updated: 2012-11-20

Locations

70 sites across 1 country: United States