Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia

Phase 3

Completed

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

• Registration Number: NCT00656994
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to determine the long-term effects of Ramelteon, once daily (QD), on endocrine function values.

Detailed Description

Insomnia is characterized by a complaint of either 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.

This study has been designed to determine the long-term (6 month) effects of Ramelteon on endocrine function values. Study participation is anticipated to be about 7 months.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-14
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in Total Serum Thyroxine.	Months 1, 2, 3, 4, 5, and 6 or Final Visit

Secondary Outcome Measures

Name	Time	Method
Change from baseline in free thyroxine.	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in thyroid stimulating hormone.	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in triiodothyronine.	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in total testosterone (men only).	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in free testosterone (men only).	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in estradiol (women only).	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in prolactin.	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in follicle stimulating hormone (women only).	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in luteinizing hormone (women only).	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in luteinizing hormone surge (women only)	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in adrenocorticotropic hormone.	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in cortisol (AM).	Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in adrenocorticotropic hormone stimulation test.	Month 6 or Final Visit