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NCT00653562 Clinical Trial

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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00653562
Other study ID # 6199-JC-0002
Secondary ID
Status Completed
Phase Phase 4
First received April 2, 2008
Last updated February 15, 2017
Start date November 2006
Est. completion date March 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 evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

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 .

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date March 2010
Est. primary completion date March 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

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
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 Sleep latency 2 days
Secondary Total hours of sleep 2 days
Secondary Frequency of intermediate awaking 2 days
Secondary Time of intermediate awaking 2 days
Secondary Patient impression 2 days
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