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

Verified by: Astellas Pharma Inc, February 2008
First Received: January 30, 2006 | Last Updated: February 25, 2009 | Phase: Phase 3 | Start Date: February 2006
Overall Status: Completed | Estimated Enrollment: 876
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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...

Brief Summary

Official Title: “FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Group-Comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -”

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

  • 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: November 2007

Intervention(s) in this Clinical Trial

  • Drug: Zolpidem MR
    • Oral
  • Drug: Zolpidem
    • Oral

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2

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
  • Safety
    • Time Frame: 2 Weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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.

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

Central Contact Study Chair Astellas Pharma Inc  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00283946

Study ID Number: 6199-CL-0007

ClinicalTrials.gov Identifier: NCT00283946

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00283946