Efficacy of Ramelteon in Adults With Chronic Insomnia
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Subjective Response to Treatment With Ramelteon in Adult Subjects With Chronic Insomnia by Utilizing an Interactive Voice Response System (IVRS) for Collecting Diary Data|
- Mean Subjective Sleep Latency determined through subject responses on morning questionnaire. [ Time Frame: Day 8 ]
- Mean Subjective Sleep Latency. [ Time Frame: Day 15 ]
- Mean Subjective Total Sleep [ Time Frame: Day 8 ]
- Mean Subjective Total Sleep [ Time Frame: Day 15 ]
- Adverse Events. [ Time Frame: Days 1, 8, and 15 or Final Visit. ]
- Clinical Laboratory Tests Hematology [ Time Frame: Day 15 or Final Visit. ]
- Clinical Laboratory Tests Chemistry. [ Time Frame: Day 15 or Final Visit. ]
- Clinical Laboratory Tests Urinalysis [ Time Frame: Day 15 or Final Visit. ]
- Vital Signs. [ Time Frame: Days 8 and 15 or Final Visit. ]
- Electrocardiograms. [ Time Frame: Day 15 or Final Visit. ]
- Physical Examinations. [ Time Frame: Day 15 or Final Visit. ]
|Study Start Date:||February 2005|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
|Experimental: Ramelteon 8 mg QD||
Ramelteon 8 mg tablets, taken orally, once daily for up to 2 weeks.
|Placebo Comparator: Placebo||
Ramelteon placebo-matching tablets, taken orally, once daily for up to 2 weeks.
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 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 being conducted to assess the treatment effects of ramelteon in adults through the use of daily entry of information into an interactive voice response system. Study participation in this study is anticipated to be about 1 month.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672724
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|Study Director:||VP Clinical Science||Takeda|