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
  Purpose

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


Condition Intervention Phase
Insomnia
Drug: Zolpidem (Myslee®)
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Mean daily sleep latency for double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 122
Study Start Date: February 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Zolpidem (Myslee®)
Oral
Other Names:
  • Myslee
  • FK199B
Experimental: 2 Drug: Zolpidem (Myslee®)
Oral
Other Names:
  • Myslee
  • FK199B
Placebo Comparator: 3 Drug: placebo
Oral

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432198

Locations
Japan
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
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00432198     History of Changes
Other Study ID Numbers: 6199-JC-0001
Study First Received: February 6, 2007
Last Updated: March 3, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
Zolpidem
Adolescent
Insomnia

Additional relevant MeSH terms:
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014