Back to resultsA Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
zolpidem MR
nitrazepam
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Insomnia, schizophrenia, manic-depressive psychosis, zolpidem
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Mean wake time after sleep onset during the double-blind period
Secondary Outcome Measures
Mean total sleep time during the double-blind period
Mean number of nightly awakenings during the double-blind period
Mean sleep latency during the double-blind period
Patient impression during the double-blind period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00374777
Brief Title
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
Insomnia, schizophrenia, manic-depressive psychosis, zolpidem
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
zolpidem MR
Other Intervention Name(s)
FK199B
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
nitrazepam
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Mean wake time after sleep onset during the double-blind period
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Mean total sleep time during the double-blind period
Time Frame
2 Weeks
Title
Mean number of nightly awakenings during the double-blind period
Time Frame
2 Weeks
Title
Mean sleep latency during the double-blind period
Time Frame
2 Weeks
Title
Patient impression during the double-blind period
Time Frame
2 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu region
Country
Japan
City
Hokkaido region
Country
Japan
City
Kansai region
Country
Japan
City
Kanto region
Country
Japan
City
Kyushu region
Country
Japan
City
Shikoku region
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140537 in the JapicCTI-RNo. field
Learn more about this trial
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
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