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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00653562
Collaborator
(none)
11
Enrollment
4
Locations
1
Arm
40
Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

Condition or Disease Intervention/Treatment Phase
Phase 4

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 .

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Patients will receive placebo in one part and zolpidem in the other part

Drug: zolpidem
Oral
Other Names:
  • Myslee

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sleep latency [2 days]

    Secondary Outcome Measures

    1. Total hours of sleep [2 days]

    2. Frequency of intermediate awaking [2 days]

    3. Time of intermediate awaking [2 days]

    4. Patient impression [2 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kansai Japan
    2 Kantou Japan
    3 Kyusyu Japan
    4 Touhoku Japan

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Chair: Use Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT00653562
    Other Study ID Numbers:
    • 6199-JC-0002
    First Posted:
    Apr 7, 2008
    Last Update Posted:
    Feb 17, 2017
    Last Verified:
    Feb 1, 2017
    Keywords provided by Astellas Pharma Inc
    polysomnography
    zolpidem
    Sleep disorders
    adolescent
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Zolpidem

    Study Results

    No Results Posted as of Feb 17, 2017