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

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

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

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

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Chair Astellas Pharma Inc  

Overall Contact: Clinical Development Administration Dept  clinicaltrials_info@jp.astellas.com

Information obtained from ClinicalTrials.gov on November 19, 2008

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