Chronic Insomnia Clinical Trial
Official title:
A Double-Blind, Dose-Response, Cross-Over Study of TAK-375 With Chronic Insomnia (Phase II Study) -- Polysomnographic Evaluation
The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia
Complaints of sleep disorder are increasing with today's aging society and changing
lifestyle. Sleep disorders not only impact one's activities of daily living, but also impede
one's social life, leading to reduced productivity and sometimes accidents through
carelessness.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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