Ramelteon in Adults With Chronic Insomnia
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Adults With Chronic Insomnia|
- 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 ]
|Study Start Date:||December 2002|
|Study Completion Date:||September 2003|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671567
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|Study Director:||VP, Clinical Science||Takeda|