Ramelteon in Adults With Chronic Insomnia

Phase 3

Completed

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

• Registration Number: NCT00671567
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in adult subjects with chronic insomnia.

Detailed Description

Insomnia is characterized by difficulties initiating and maintaining sleep or complaints of nonrestorative 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 a 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.

This study is designed to determine the safety and efficacy of 35-day treatment of chronic insomnia with Ramelteon, using subjective measures of sleep. Total subject participation time in this study is expected to be approximately 2 months.

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-05
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 848

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ramelteon 16 mg QD	Ramelteon	-
Ramelteon 8 mg QD	Ramelteon	-

Primary Outcome Measures

Name	Time	Method
Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind treatment.	Weeks 1, 2, 3, 4, and 5 or Final Visit

Secondary Outcome Measures

Name	Time	Method
Mean Subjective Sleep Latency per subject diary, over the week preceding the Day 15, Day 22, Day 29, and Day 36 Visits.	Weeks 2, 3, 4, and 5 or Final Visit
Subjective Total Sleep Time	Weeks 1, 2, 3, 4, and 5 or Final Visit
Subjective Number of Awakenings.	Weeks 1, 2, 3, 4, and 5 or Final Visit
Subjective Ease of Falling Back to Sleep after Awakening.	Weeks 1, 2, 3, 4, and 5 or Final Visit
Subjective Sleep Quality.	Weeks 1, 2, 3, 4, and 5 or Final Visit
Clinician's Clinical Global Impression	Weeks 1, 2, 3, 4, and 5 or Final Visit