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Completed

NCT Number: NCT00653562

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

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kansai, Japan

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zolpidem

Drug

Oral

Other names: Myslee

Primary outcomes

  1. Sleep latency

    Time frame: 2 days

Secondary outcomes

  1. Total hours of sleep

    Time frame: 2 days

  2. Frequency of intermediate awaking

    Time frame: 2 days

  3. Time of intermediate awaking

    Time frame: 2 days

  4. Patient impression

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Apr 7, 2008
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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