NCT00671086

Efficacy of Ramelteon in Subjects With Chronic Insomnia

A Phase 3, Open-label, Fixed-dose Study to Determine the Safety of Long-term Administration of TAK-375 in Subjects With Chronic Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,213 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.

Detailed description

Insomnia is characterized by difficulties initiating and maintaining sleep or complaints of non-restorative 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 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. The purpose of this study is to obtain data in support the safety of long-term use of Ramelteon for insomnia, and to determine whether there are any adverse effects associated with extended use. Participation in this study is expected to be about. Participation in this study is anticipated to be approximately 13 months.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
DRUG	Ramelteon	Subjects 65 yrs of age and older will take Ramelteon 8 mg, tablets, orally, once nightly for up to one year.
DRUG	Ramelteon	Subjects between 18 and 64 years of age will take Ramelteon 16 mg, tablets, orally, once nightly for up to one year.

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2008-05-05
• Last updated: 2012-02-28

Locations

122 sites across 1 country: United States