Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.

Phase 3

Completed

• Conditions: Chronic Insomnia
• Interventions: Drug: Ramelteon and Placebo (9 possible combinations total)

• Registration Number: NCT00671294
• Lead Sponsor: Takeda

Brief Summary

This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily (QD), in elderly subjects with chronic insomnia.

Detailed Description

Insomnia is characterized by a complaint of difficulties initiating and maintaining sleep or 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., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.

Participation in this study is anticipated to be about 2 months.

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2003-07
• Study Completion: 2003-07
• 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: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ramelteon and Placebo QD (9 possible combinations total)	Ramelteon and Placebo (9 possible combinations total)	-

Primary Outcome Measures

Name	Time	Method
Mean latency to persistent sleep of 2-night per polysomnogram recordings, from nights 1 and 2 of each Treatment Period.	Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.

Secondary Outcome Measures

Name	Time	Method
Subjective Number of Awakenings.	Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Sleep Efficiency.	Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Wake Time after Sleep Onset.	Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Subjective Sleep Latency.	Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Sleep Quality.	Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Ease of Falling Back to Sleep after Awakening.	Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Total Sleep Time.	Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Total Sleep Time.	Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Number of Awakenings after Persistent Sleep Onset.	Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Subjective Wake Time after Sleep Onset.	Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.