A Double-Blind, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia

H. Lundbeck A/S0 个研究点目标入组 138 人开始时间: 2006年9月1日最近更新: 2015年1月14日

适应症

试验速览

阶段: 3 期
状态: 终止
发起方: H. Lundbeck A/S
入组人数: 138
主要终点: Wake after sleep onset and Latency to persistent sleep

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of Primary Insomnia
•Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
•Patient is willing to avoid alcohol on PSG visits
•Patient will avoid napping during the course of the study
•Patient's bedtime is between 9pm and 1am

排除标准

•History of substance abuse, bipolar disorder or psychotic disorder
•Difficulty sleeping due to other medical condition
•History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
•History of neoplastic malignancy within the last 5 years
•Positive alcohol breath test during the screening visits

结局指标

主要结局

Wake after sleep onset and Latency to persistent sleep

次要结局

Subjective total sleep time and subjective time to sleep onset

研究者

发起方

H. Lundbeck A/S

申办方类型

Industry

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