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NCT00432198 Clinical Trial

Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00432198
Other study ID # 6199-JC-0001
Secondary ID
Status Completed
Phase Phase 4
First received February 6, 2007
Last updated February 15, 2017
Start date February 2007
Est. completion date January 2010

Study information
Verified date February 2017
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean daily sleep latency for double-blind period 2 Weeks
Secondary Mean daily total hours of sleep 2 Weeks
Secondary Mean daily frequency of intermediate awaking 2 Weeks
Secondary Mean daily time of intermediate awaking 2 Weeks
Secondary Impression of patient for double-blind period 2 Weeks
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