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

April 2, 2008
April 6, 2010
November 2006
March 2010   (final data collection date for primary outcome measure)
Sleep latency [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00653562 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

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 .

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Sleep Initiation and Maintenance Disorders
  • Insomnia
Drug: zolpidem
Oral
Other Name: Myslee
Experimental: 1
Patients will receive placebo in one part and zolpidem in the other part
Intervention: Drug: zolpidem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00653562
6199-JC-0002
No
Director, Astellas Pharma Inc.
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
April 2010

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