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Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00432198
Recruitment Status : Completed
First Posted : February 7, 2007
Last Update Posted : February 17, 2017
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Insomnia Drug: Zolpidem (Myslee®) Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia
Study Start Date : February 2007
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Zolpidem (Myslee®)
Other Names:
  • Myslee
  • FK199B
Experimental: 2
Drug: Zolpidem (Myslee®)
Other Names:
  • Myslee
  • FK199B
Placebo Comparator: 3
Drug: placebo

Primary Outcome Measures :
  1. Mean daily sleep latency for double-blind period [ Time Frame: 2 Weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00432198

Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushyu region, Japan
Shikoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00432198     History of Changes
Other Study ID Numbers: 6199-JC-0001
First Posted: February 7, 2007    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action