Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients

Completed

• Conditions: Insomnia
• Interventions: Drug: Eszopiclone

• Registration Number: NCT02452684
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-01
• Primary Completion: 2014-11-11
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-25
• Study Completion: 2015-12-22
• Status Verified: 2017-01
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4876

Inclusion Criteria

1. Insomnia participants who did not take eszopiclone before assessment
2. Participants who receive assessment by using sleep questionaries

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with insomnia	Eszopiclone	Participants with insomnia who will receive eszopiclone, per approved label.

Primary Outcome Measures

Name	Time	Method
Assessment of overall improvement	Up to 4 weeks	Participants will be interviewed regarding sleep improvement at 4 weeks after first dose or discontinuation relative to predose, and select the appropriate answer of: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Up to 4 weeks