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

Verified by: Astellas Pharma Inc, July 2008
First Received: September 8, 2006 | Last Updated: October 20, 2009 | Phase: Phase 3 | Start Date: August 2006
Overall Status: Completed | Estimated Enrollment: 450
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A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Chair Astellas Pharma Inc  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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