Status:
COMPLETED
Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Insomnia
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
12-18 years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography
Detailed 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 .
Eligibility Criteria
Inclusion
- Patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00653562
Start Date
November 1 2006
End Date
March 1 2010
Last Update
February 17 2017
Active Locations (4)
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1
Kansai, Japan
2
Kantou, Japan
3
Kyusyu, Japan
4
Tōhoku, Japan