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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00374777
First received: September 8, 2006
Last updated: August 19, 2014
Last verified: August 2014

September 8, 2006
August 19, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Mean number of nightly awakenings during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Mean sleep latency during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Patient impression during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
Both
20 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00374777
6199-CL-0008
No
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