Efficacy of Ramelteon in Subjects With Chronic Insomnia

Phase 3

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Drug: Ramelteon

• Registration Number: NCT00671086
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects 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 selective 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.

The purpose of this study is to obtain data in support the safety of long-term use of Ramelteon for insomnia, and to determine whether there are any adverse effects associated with extended use. Participation in this study is expected to be about. Participation in this study is anticipated to be approximately 13 months.

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-05
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1213

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	-
Ramelteon 16 mg QD	Ramelteon	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Chemistry Laboratory Tests.	Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Menstrual Diary Results.	Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Adverse Events.	Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit.
Change from Baseline in Hematology Laboratory Tests.	Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Change from Baseline in Urinalysis Laboratory Tests.	Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Electrocardiograms.	Month 6 and 12 or Final Visit.
Physical Examinations.	Months 2, 4, 8, 10, and 12 or Final Visit.
Change from Baseline in Vital Signs.	Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Subjective Total Sleep Time.	Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.
Clinical Global Impression Scale.	Months 6 and 12 or Final Visit.
Change from Baseline in Subjective Sleep Latency.	Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.