- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108351
Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone as a Positive Control
October 4, 2022 updated by: Taisho Pharmaceutical Co., Ltd.
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
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
-
-
-
Fukuoka, Japan
- The medical facility selected by Taisho Pharmaceutical Co., Ltd
-
Fukuoka, Japan
- Taisho Pharmaceutical Co., Ltd selected site
-
-
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
21 years to 64 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening inspection
- No visual impairment (enable to correct the vision with eyeglasses or contact lens)
- Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- History of drug and food allergy
- Hypersensitivity to zopiclone
- Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
- Other protocol defined inclusion criteria could apply
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: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Driving with simulator program for SDLP measurement
Intervention Description: Driving with simulator program for DCV measurement
Driving with simulator program for BRT measurement
|
EXPERIMENTAL: Zopiclone
|
Driving with simulator program for SDLP measurement
Intervention Description: Driving with simulator program for DCV measurement
Driving with simulator program for BRT measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Standard Deviation of Lateral Position (SDLP)
Time Frame: 60 min
|
60 min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Distance Coefficient of Variation (DCV)
Time Frame: 5 min
|
5 min
|
Brake Reaction Time (BRT)
Time Frame: 5 min
|
5 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (ACTUAL)
October 7, 2019
Primary Completion (ACTUAL)
February 11, 2020
Study Completion (ACTUAL)
February 11, 2020
Study Registration Dates
First Submitted
September 26, 2019
First Submitted That Met QC Criteria
September 26, 2019
First Posted (ACTUAL)
September 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 6, 2022
Last Update Submitted That Met QC Criteria
October 4, 2022
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DS-204-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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