Efficacy of Ramelteon in Adults With Chronic Insomnia

Phase 3

Terminated

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

• Registration Number: NCT00672724
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), in adults 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 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.

This study is being conducted to assess the treatment effects of ramelteon in adults through the use of daily entry of information into an interactive voice response system. Study participation in this study is anticipated to be about 1 month.

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1081

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Subjective Sleep Latency determined through subject responses on morning questionnaire.	Day 8

Secondary Outcome Measures

Name	Time	Method
Mean Subjective Sleep Latency.	Day 15
Mean Subjective Total Sleep	Day 15
Adverse Events.	Days 1, 8, and 15 or Final Visit.
Clinical Laboratory Tests Hematology	Day 15 or Final Visit.
Clinical Laboratory Tests Chemistry.	Day 15 or Final Visit.
Clinical Laboratory Tests Urinalysis	Day 15 or Final Visit.
Vital Signs.	Days 8 and 15 or Final Visit.
Electrocardiograms.	Day 15 or Final Visit.
Physical Examinations.	Day 15 or Final Visit.