Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

Phase 4

Completed

• Conditions: Insomnia
• Interventions: Drug: Zolpidem (Myslee®); Drug: placebo

• Registration Number: NCT00432198
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-06
• Study First Submitted QC: 2007-02-06
• Study First Posted: 2007-02-07
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Zolpidem (Myslee®)	Oral
2	Zolpidem (Myslee®)	Oral
3	placebo	Oral

Primary Outcome Measures

Name	Time	Method
Mean daily sleep latency for double-blind period	2 Weeks

Secondary Outcome Measures

Name	Time	Method
Impression of patient for double-blind period	2 Weeks
Mean daily time of intermediate awaking	2 Weeks
Mean daily total hours of sleep	2 Weeks
Mean daily frequency of intermediate awaking	2 Weeks