- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374777
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
August 19, 2014 updated by: Astellas Pharma Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
450
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chubu region, Japan
-
Hokkaido region, Japan
-
Kansai region, Japan
-
Kanto region, Japan
-
Kyushu region, Japan
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Shikoku region, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
oral
Other Names:
|
Experimental: 2
|
oral
Other Names:
|
Placebo Comparator: 4
|
oral
|
Active Comparator: 3
|
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean wake time after sleep onset during the double-blind period
Time Frame: 2 Weeks
|
2 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean total sleep time during the double-blind period
Time Frame: 2 Weeks
|
2 Weeks
|
Mean number of nightly awakenings during the double-blind period
Time Frame: 2 Weeks
|
2 Weeks
|
Mean sleep latency during the double-blind period
Time Frame: 2 Weeks
|
2 Weeks
|
Patient impression during the double-blind period
Time Frame: 2 Weeks
|
2 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
September 8, 2006
First Submitted That Met QC Criteria
September 8, 2006
First Posted (Estimate)
September 11, 2006
Study Record Updates
Last Update Posted (Estimate)
August 20, 2014
Last Update Submitted That Met QC Criteria
August 19, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Sleep Aids, Pharmaceutical
- GABA-A Receptor Agonists
- GABA Agonists
- Zolpidem
- Nitrazepam
Other Study ID Numbers
- 6199-CL-0008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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