Back to resultsZolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Primary Purpose
Insomnia, Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
zolpidem
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring polysomnography, zolpidem, Sleep disorders, adolescent
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patients will receive placebo in one part and zolpidem in the other part
Outcomes
Primary Outcome Measures
Sleep latency
Secondary Outcome Measures
Total hours of sleep
Frequency of intermediate awaking
Time of intermediate awaking
Patient impression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00653562
Brief Title
Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Official Title
Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep Initiation and Maintenance Disorders
Keywords
polysomnography, zolpidem, Sleep disorders, adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients will receive placebo in one part and zolpidem in the other part
Intervention Type
Drug
Intervention Name(s)
zolpidem
Other Intervention Name(s)
Myslee
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Sleep latency
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Total hours of sleep
Time Frame
2 days
Title
Frequency of intermediate awaking
Time Frame
2 days
Title
Time of intermediate awaking
Time Frame
2 days
Title
Patient impression
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Kyusyu
Country
Japan
City
Touhoku
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=141
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
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