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Study to Evaluate Efficacy, Safety and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder Without Psychiatric Comorbidity

Insomnia Clinical Trial

Official title:
A Randomized, Placebo-controlled, 2-way Crossover, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder Without Psychiatric Comorbidity

Clinical Trial Summary

The primary purpose of this study is to investigate the effect of JNJ-42847922 (change versus placebo) on sleep efficiency (SE) measured by polysomnography (PSG) after single and multiple dose administration to participants with insomnia disorder without psychiatric comorbidity.

Clinical Trial Description

This is a multi-center, randomized (study medication assigned to participants by chance), placebo-controlled, double-blind (neither physician nor participant knows the identity of the assigned treatment), 2-way cross-over study of JNJ-42847922 participants with insomnia disorder without psychiatric comorbidity. The study consists of following phases: screening (28 days prior to Day 1), a double-blind treatment phase (consists of 5-day treatments, either JNJ-42847922 or placebo in subsequent 2-treatment periods, each separated with washout period of 5 to 9 days), and a follow-up examination (7 to 14 days after last dose administration). Participants' safety will be monitored throughout the study. ;

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Clinical Trial Details
NCT number NCT02464046
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Completed
Phase Phase 2
Start date July 27, 2015
Completion date December 2, 2015
View Details
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