A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients

Phase 3

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Drug: placebo; Drug: zolpidem MR; Drug: nitrazepam

• Registration Number: NCT00374777
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-09-08
• Study First Submitted QC: 2006-09-08
• Study First Posted: 2006-09-11
• Primary Completion: 2008-05
• Study Completion: 2008-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.

Exclusion Criteria

• Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious cardiac disorders; serious hepatic impairment; serious renal diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	placebo	-
1	zolpidem MR	-
2	zolpidem MR	-
3	nitrazepam	-

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