NCT00671255

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 829 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This purpose of this study is to evaluate the safety and effectiveness of Ramelteon, once daily (QD), in elderly participants with chronic insomnia.

Detailed description

Insomnia is characterized by a complaint of 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 selective melatonin-1 receptor agonist under development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders. Ramelteon is the first candidate in a novel class of drugs based on this mechanism. Based on non-clinical and clinical studies completed to date, TAK-375 has the potential to offer unique advantages relative to approved hypnotics in terms of its pharmacological profile and its selectivity to the melatonin-1 receptor. This study is designed to determine the safety and efficacy of 35-day treatment of chronic insomnia with ramelteon. Participation in this study is anticipated to be approximately 2 months.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	Ramelteon	Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.
DRUG	Ramelteon	Ramelteon 8 mg, tablets, orally, once daily for up to 5 weeks.
DRUG	Placebo	Ramelteon placebo-matching, tablets, orally, each night for up to 35 consecutive days.

Timeline

• Start date: 2002-12-01
• Primary completion: 2004-01-01
• Completion: 2004-01-01
• First posted: 2008-05-05
• Last updated: 2012-02-28

Locations

115 sites across 2 countries: United States, Canada