Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3
NCT ID: NCT03572985
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2018-06-27
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Blood alcohol concentration (BAC) level 0.025 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025%
Road-tracking test
Driving with simulator program for SDLP measurement
Car-following test
Driving with simulator program for DCV measurement
Harsh-braking test
Driving with simulator program for BRT measurement
BAC level 0.05 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%
Road-tracking test
Driving with simulator program for SDLP measurement
Car-following test
Driving with simulator program for DCV measurement
Harsh-braking test
Driving with simulator program for BRT measurement
BAC level 0.09 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%
Road-tracking test
Driving with simulator program for SDLP measurement
Car-following test
Driving with simulator program for DCV measurement
Harsh-braking test
Driving with simulator program for BRT measurement
BAC level 0 %
Drink beverages containing non alcohol
Road-tracking test
Driving with simulator program for SDLP measurement
Car-following test
Driving with simulator program for DCV measurement
Harsh-braking test
Driving with simulator program for BRT measurement
Interventions
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Road-tracking test
Driving with simulator program for SDLP measurement
Car-following test
Driving with simulator program for DCV measurement
Harsh-braking test
Driving with simulator program for BRT measurement
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Alcohol dependence, drug dependence or abnormal drunken (including past history)
* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
21 Years
64 Years
MALE
Yes
Sponsors
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Nagoya University
OTHER
Taisho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shigeru Okuyama
Role: STUDY_DIRECTOR
Taisho Pharmaceutical Co., Ltd.
Locations
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Taisho Pharmaceutical Co., Ltd selected site
Fukuoka, , Japan
Countries
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References
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Iwata M, Iwamoto K, Omura T, Ando M, Ozaki N. Protocol for the development and validation of a driving simulator for evaluating the influence of drugs on driving performance. Medicine (Baltimore). 2019 Feb;98(8):e14613. doi: 10.1097/MD.0000000000014613.
Other Identifiers
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JapicCTI-184006
Identifier Type: OTHER
Identifier Source: secondary_id
DS-204-03
Identifier Type: -
Identifier Source: org_study_id
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