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Trial record 37 of 118 for:    ZOLPIDEM AND AIDS

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

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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

Tracking Information
First Submitted Date  ICMJE April 2, 2008
First Posted Date  ICMJE April 7, 2008
Last Update Posted Date February 17, 2017
Study Start Date  ICMJE November 2006
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2008)
Sleep latency [ Time Frame: 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00653562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2008)
  • Total hours of sleep [ Time Frame: 2 days ]
  • Frequency of intermediate awaking [ Time Frame: 2 days ]
  • Time of intermediate awaking [ Time Frame: 2 days ]
  • Patient impression [ Time Frame: 2 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Official Title  ICMJE Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Brief Summary To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Intervention  ICMJE Drug: zolpidem
Oral
Other Name: Myslee
Study Arms  ICMJE Experimental: 1
Patients will receive placebo in one part and zolpidem in the other part
Intervention: Drug: zolpidem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2010)
11
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2008)
10
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00653562
Other Study ID Numbers  ICMJE 6199-JC-0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Use Central Contact Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date February 2017

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