Status:
COMPLETED
Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Insomnia
Eligibility:
All Genders
12-18 years
Phase:
PHASE4
Brief Summary
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial
Eligibility Criteria
Inclusion
- 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
- 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 :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00432198
Start Date
February 1 2007
End Date
January 1 2010
Last Update
February 17 2017
Active Locations (7)
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1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kansai Region, Japan