Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00432198
First received: February 6, 2007
Last updated: March 3, 2010
Last verified: March 2010

February 6, 2007
March 3, 2010
February 2007
January 2010   (final data collection date for primary outcome measure)
Mean daily sleep latency for double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Mean daily frequency of intermediate awaking [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Mean daily time of intermediate awaking [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Impression of patient for double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Insomnia
  • Drug: Zolpidem (Myslee®)
    Oral
    Other Names:
    • Myslee
    • FK199B
  • Drug: placebo
    Oral
  • Experimental: 1
    Intervention: Drug: Zolpidem (Myslee®)
  • Experimental: 2
    Intervention: Drug: Zolpidem (Myslee®)
  • Placebo Comparator: 3
    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
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00432198
6199-JC-0001
No
Director, Astellas Pharma Inc.
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
March 2010

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