Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography

Verified by: Astellas Pharma Inc, April 2010
First Received: April 2, 2008 | Last Updated: April 6, 2010 | Phase: Phase 4 | Start Date: November 2006
Overall Status: Completed | Estimated Enrollment: 11
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To evaluate the efficacy of zolpidem for adolescent insomniacs with...

Brief Summary

Official Title: “Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography”

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2010

Detailed Clinical Trial Description

The study consists of two parts. All patients will receive placebo in one part and Zolpidem in the other part in a single blind manner. Efficacy will be measured with polysomnography .

Intervention(s) in this Clinical Trial

  • Drug: zolpidem
    • Oral

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Patients will receive placebo in one part and zolpidem in the other part

Outcome Measures for this Clinical Trial

Primary Measures

  • Sleep latency
    • Time Frame: 2 days
      Safety Issue?: No

Secondary Measures

  • Total hours of sleep
    • Time Frame: 2 days
      Safety Issue?: No
  • Frequency of intermediate awaking
    • Time Frame: 2 days
      Safety Issue?: No
  • Time of intermediate awaking
    • Time Frame: 2 days
      Safety Issue?: No
  • Patient impression
    • Time Frame: 2 days
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10

Exclusion Criteria:

  • Patients with schizophrenia or manic-depressive illness
  • Patients with insomnia caused by physical diseases
  • Patients having a history of hypersensitivity to zolpidem
  • Patients with attention-deficit hyperactivity disorder

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 18 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 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653562

Study ID Number: 6199-JC-0002

ClinicalTrials.gov Identifier: NCT00653562

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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