NCT00247390

Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

A Randomised, Double-blind, Placebo-controlled Study to Determine the Long-term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).

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. An ideal treatment for chronic insomnia would include administration of therapy for an extended period. Specifically, it should be safe and effective for a period longer than the 7 to 10 days to which use of the current drugs approved for short-term use are limited. Because of the absence of evidence of residual effects in pre-clinical studies and phase 2 and 3 clinical trials, ramelteon may be a candidate for extended use. As chronic insomnia becomes more prevalent, there is a need to assess the long-term efficacy and safety of nightly dosing with ramelteon in the general population. Study participation is anticipated to be about 8 months and 3 weeks.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	Ramelteon	Ramelteon 8 mg, tablets, orally, once daily for up to 42 weeks.
DRUG	Placebo	Ramelteon placebo-matching tablets, orally, once daily for up to 42 weeks.

Timeline

• Start date: 2005-07-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-11-01
• Last updated: 2010-06-03

Locations

48 sites across 9 countries: United States, Australia, Belgium, Czechia, Finland, France, Germany, Italy, Russia