Official Title: “FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Placebo- and Nitrazepam-Controlled, Group-Comparison Study in Patients With Insomnia Associated With Schizophrenia and Manic-Depressive Psychosis”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: zolpidem MR
  • oral
• Drug: nitrazepam
  • oral
• Drug: placebo
  • oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Active Comparator: 3
• Placebo Comparator: 4

Primary Measures

• Mean wake time after sleep onset during the double-blind period
  • Time Frame: 2 Weeks
    Safety Issue?: No

Secondary Measures

• Mean total sleep time during the double-blind period
  • Time Frame: 2 Weeks
    Safety Issue?: No
• Mean number of nightly awakenings during the double-blind period
  • Time Frame: 2 Weeks
    Safety Issue?: No
• Mean sleep latency during the double-blind period
  • Time Frame: 2 Weeks
    Safety Issue?: No
• Patient impression during the double-blind period
  • Time Frame: 2 Weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Chair Astellas Pharma Inc  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00374777

Study ID Number: 6199-CL-0008

ClinicalTrials.gov Identifier: NCT00374777

Health Authority: Japan: Ministry of Health, Labor and Welfare