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Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00432198
First Posted: February 7, 2007
Last Update Posted: February 17, 2017
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
February 6, 2007
February 7, 2007
February 17, 2017
February 2007
January 2010   (Final data collection date for primary outcome measure)
Mean daily sleep latency for double-blind period [ Time Frame: 2 Weeks ]
Mean daily sleep latency for double-blind period
Complete list of historical versions of study NCT00432198 on ClinicalTrials.gov Archive Site
  • Mean daily total hours of sleep [ Time Frame: 2 Weeks ]
  • Mean daily frequency of intermediate awaking [ Time Frame: 2 Weeks ]
  • Mean daily time of intermediate awaking [ Time Frame: 2 Weeks ]
  • Impression of patient for double-blind period [ Time Frame: 2 Weeks ]
Mean daily total hours of sleep, Mean daily frequency of intermediate awaking , Mean daily time of intermediate awaking, Impression of patient for double-blind period
Not Provided
Not Provided
 
Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Insomnia
  • Drug: Zolpidem (Myslee®)
    Oral
    Other Names:
    • Myslee
    • FK199B
  • Drug: placebo
    Oral
  • Experimental: 1
    Oral
    Intervention: Drug: Zolpidem (Myslee®)
  • Experimental: 2
    Oral
    Intervention: Drug: Zolpidem (Myslee®)
  • Placebo Comparator: 3
    Oral
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00432198
6199-JC-0001
No
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP