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

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.
 
ClinicalTrials.gov Identifier: NCT00653562
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

Condition or disease Intervention/treatment Phase
Insomnia Sleep Initiation and Maintenance Disorders Drug: zolpidem Phase 4

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 .
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Study Start Date : November 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Patients will receive placebo in one part and zolpidem in the other part
 Drug: zolpidem
Oral
Other Name: Myslee


Outcome Measures
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Primary Outcome Measures :
  1. Sleep latency [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Total hours of sleep [ Time Frame: 2 days ]
  2. Frequency of intermediate awaking [ Time Frame: 2 days ]
  3. Time of intermediate awaking [ Time Frame: 2 days ]
  4. Patient impression [ Time Frame: 2 days ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653562


Locations
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Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Chair: Use Central Contact Astellas Pharma Inc
More Information
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Additional Information:

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00653562    
Other Study ID Numbers: 6199-JC-0002
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Keywords provided by Astellas Pharma Inc:
polysomnography
zolpidem
Sleep disorders
adolescent
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Sleep Aids, Pharmaceutical
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action