Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

Verified by: Astellas Pharma Inc, March 2010
First Received: February 6, 2007 | Last Updated: March 3, 2010 | Phase: Phase 4 | Start Date: February 2007
Overall Status: Completed | Estimated Enrollment: 122
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To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled...

Brief Summary

Official Title: “Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia”

To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial

  • 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: January 2010

Intervention(s) in this Clinical Trial

  • Drug: Zolpidem (Myslee®)
    • Oral
  • Drug: placebo
    • Oral

Arms, Groups and Cohorts in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean daily sleep latency for double-blind period
    • Time Frame: 2 Weeks
      Safety Issue?: No

Secondary Measures

  • Mean daily total hours of sleep
    • Time Frame: 2 Weeks
      Safety Issue?: No
  • Mean daily frequency of intermediate awaking
    • Time Frame: 2 Weeks
      Safety Issue?: No
  • Mean daily time of intermediate awaking
    • Time Frame: 2 Weeks
      Safety Issue?: No
  • Impression of patient for double-blind period
    • Time Frame: 2 Weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10
  • patients whose age at the time of obtaining consent is 12 years or over and 18 years or below

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/NCT00432198

Study ID Number: 6199-JC-0001

ClinicalTrials.gov Identifier: NCT00432198

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

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