Chronic Insomnia Clinical Trial
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
The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), in adults with chronic insomnia.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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