NCT00237497

Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Ramelteon Compared to Placebo With Zopiclone as a Reference Arm in Adults With Chronic Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia

Detailed description

A vast majority of people are affected by chronic insomnia in the western world. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some time in their life with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents. This study will examine the effect of ramelteon on balance/postural stability on Night 14 at peak plasma concentration levels, compared with placebo and using zopiclone as the reference arm.

Conditions

• Balance

Interventions

Type	Name	Description
DRUG	Ramelteon	Ramelteon 8 mg, tablets, orally, once daily for up to 28 nights.
DRUG	Zopiclone	Zopiclone 7.5 mg, tablets, orally, once daily for up to 28 nights.
DRUG	Placebo	Placebo-matching tablets, orally, once daily for up to 28 nights.

Timeline

• Start date: 2005-07-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2005-10-12
• Last updated: 2012-02-02

Locations

1 site across 1 country: United Kingdom