Ramelteon in Adults With Chronic Insomnia
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|ClinicalTrials.gov Identifier: NCT00671567|
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : November 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Insomnia||Drug: Ramelteon Drug: Placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||848 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Adults With Chronic Insomnia|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||September 2003|
|Actual Study Completion Date :||September 2003|
|Experimental: Ramelteon 8 mg QD||
Ramelteon, 8 mg, tablets, orally, once daily for up to 5 weeks.
|Experimental: Ramelteon 16 mg QD||
Ramelteon, 16 mg, tablets, orally, once daily for up to 5 weeks.
|Placebo Comparator: Placebo||
Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks.
- Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind treatment. [ Time Frame: Weeks 1, 2, 3, 4, and 5 or Final Visit ]
- Mean Subjective Sleep Latency per subject diary, over the week preceding the Day 15, Day 22, Day 29, and Day 36 Visits. [ Time Frame: Weeks 2, 3, 4, and 5 or Final Visit ]
- Subjective Total Sleep Time [ Time Frame: Weeks 1, 2, 3, 4, and 5 or Final Visit ]
- Subjective Number of Awakenings. [ Time Frame: Weeks 1, 2, 3, 4, and 5 or Final Visit ]
- Subjective Ease of Falling Back to Sleep after Awakening. [ Time Frame: Weeks 1, 2, 3, 4, and 5 or Final Visit ]
- Subjective Sleep Quality. [ Time Frame: Weeks 1, 2, 3, 4, and 5 or Final Visit ]
- Clinician's Clinical Global Impression [ Time Frame: Weeks 1, 2, 3, 4, and 5 or Final Visit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671567
|Study Director:||VP, Clinical Science||Takeda|