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OpenTrials
Completed

NCT Number: NCT00432198

Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases 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

Chubu Region, Japan

Loading trial locations.

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
  • 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

Treatment and study plan

Zolpidem (Myslee®)

Drug

Oral

Other names: Myslee, FK199B

Placebo

Drug

Oral

Primary outcomes

  1. Mean daily sleep latency for double-blind period

    Time frame: 2 Weeks

Secondary outcomes

  1. Mean daily total hours of sleep

    Time frame: 2 Weeks

  2. Mean daily frequency of intermediate awaking

    Time frame: 2 Weeks

  3. Mean daily time of intermediate awaking

    Time frame: 2 Weeks

  4. Impression of patient for double-blind period

    Time frame: 2 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 7, 2007
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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