Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.

Phase 4

Completed

• Conditions: Chronic Insomnia
• Interventions: Drug: Placebo; Drug: Ramelteon

• Registration Number: NCT00414102
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to determine the subjective treatment effects of ramelteon, once daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in adults with chronic insomnia.

Detailed Description

Approximately 60 to 70 million adults in the United States alone are affected by insomnia. 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.

Ramelteon is marketed for the treatment of insomnia characterized by difficulty with sleep onset under the brand name of Rozerem™.

This study will be comprised of two groups of subjects, 1) an outpatient group and 2) an inpatient group. The inpatient group will be used as reference arm as previously conducted studies in the sleep laboratory setting. Study participation is anticipated to be about 50 days (approximately 1.75 months).

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-21
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2010-05
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 552

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo QD	Placebo	-
Ramelteon 8 mg QD	Ramelteon	-

Primary Outcome Measures

Name	Time	Method
Average subjective Sleep Latency from Day 15 to Day 21	Day 22

Secondary Outcome Measures

Name	Time	Method
Subjective Measures of Sleep Latency.	Weeks 1 and 2 or Final Visit
Subjective Total Sleep Time.	Weeks 1, 2 and 3 or Final Visit
Wake Time after Sleep Onset	Weeks 1, 2 and 3 or Final Visit
Number of Awakenings.	Weeks 1, 2 and 3 or Final Visit
Quality of Sleep.	Weeks 1, 2 and 3 or Final Visit
Rebound insomnia assessed from Nights 22 to 28 via self-reported sleep latency.	Day 29