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Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00653562
First received: April 2, 2008
Last updated: April 6, 2010
Last verified: April 2010
History of Changes
  Purpose

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Insomnia
 Drug: zolpidem
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Sleep latency [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total hours of sleep [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Frequency of intermediate awaking [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Time of intermediate awaking [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Patient impression [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: November 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients will receive placebo in one part and zolpidem in the other part
 Drug: zolpidem
Oral
Other Name: Myslee

Detailed Description:

The study consists of two parts. All patients will receive placebo in one part and Zolpidem in the other part in a single blind manner. Efficacy will be measured with polysomnography .

  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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653562

Locations
Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Touhoku, 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: NCT00653562     History of Changes
Other Study ID Numbers: 6199-JC-0002
Study First Received: April 2, 2008
Last Updated: April 6, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Sleep disorders
zolpidem
polysomnography
adolescent

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
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 May 22, 2013