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A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374777
First Posted: September 11, 2006
Last Update Posted: August 20, 2014
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
September 8, 2006
September 11, 2006
August 20, 2014
August 2006
May 2008   (Final data collection date for primary outcome measure)
Mean wake time after sleep onset during the double-blind period [ Time Frame: 2 Weeks ]
Not Provided
Complete list of historical versions of study NCT00374777 on ClinicalTrials.gov Archive Site
  • Mean total sleep time during the double-blind period [ Time Frame: 2 Weeks ]
  • Mean number of nightly awakenings during the double-blind period [ Time Frame: 2 Weeks ]
  • Mean sleep latency during the double-blind period [ Time Frame: 2 Weeks ]
  • Patient impression during the double-blind period [ Time Frame: 2 Weeks ]
Not Provided
Not Provided
Not Provided
 
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Placebo- and Nitrazepam-Controlled, Group-Comparison Study in Patients With Insomnia Associated With Schizophrenia and Manic-Depressive Psychosis
A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Drug: zolpidem MR
    oral
    Other Name: FK199B
  • Drug: nitrazepam
    oral
  • Drug: placebo
    oral
  • Experimental: 1
    Intervention: Drug: zolpidem MR
  • Experimental: 2
    Intervention: Drug: zolpidem MR
  • Active Comparator: 3
    Intervention: Drug: nitrazepam
  • Placebo Comparator: 4
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
June 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.

Exclusion Criteria:

  • Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious cardiac disorders; serious hepatic impairment; serious renal diseases.
Sexes Eligible for Study: All
20 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00374777
6199-CL-0008
No
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
August 2014

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