A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia

Phase 3

Completed

• Conditions: Sleep Disorders; Sleep Initiation and Maintenance Disorders
• Interventions: Drug: Zolpidem MR; Drug: Zolpidem

• Registration Number: NCT00283946
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-30
• Study First Submitted QC: 2006-01-30
• Study First Posted: 2006-01-31
• Study Start: 2006-02
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 876

Inclusion Criteria

• Clinical diagnosis of nonorganic insomnia.
• Must be able to swallow tablets

Exclusion Criteria

• Allergic reactions to zolpidem (Myslee)
• Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Zolpidem MR	-
2	Zolpidem	-

Primary Outcome Measures

Name	Time	Method
Mean wake time after sleep onset during the double-blind period	2 Weeks

Secondary Outcome Measures

Name	Time	Method
Safety	2 Weeks
Mean total sleep time during the double-blind period	2 Weeks
Mean sleep latency during the double-blind period	2 Weeks
Mean number of nightly awakenings during the double-blind period	2 Weeks
Patient impression during the double-blind period	2 Weeks