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
NCT ID: NCT04108351
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
28 participants
INTERVENTIONAL
2019-10-07
2020-02-11
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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Zopiclone
Road-tracking test
Driving with simulator program for SDLP measurement
Car-following test
Intervention Description: Driving with simulator program for DCV measurement
Harsh-braking test
Driving with simulator program for BRT measurement
Placebo
Road-tracking test
Driving with simulator program for SDLP measurement
Car-following test
Intervention Description: 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
Intervention Description: 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
* Hypersensitivity to zopiclone
* 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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Taisho Director
Role: STUDY_DIRECTOR
Taisho Pharmaceutical Co., Ltd.
Locations
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Taisho Pharmaceutical Co., Ltd selected site
Fukuoka, , Japan
The medical facility selected by Taisho Pharmaceutical Co., Ltd
Fukuoka, , Japan
Countries
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References
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Iwata M, Iwamoto K, Kambe D, Tachibana N, Ando M, Ozaki N. 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: Study Protocol Clinical Trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Mar;99(12):e19395. doi: 10.1097/MD.0000000000019395.
Other Identifiers
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DS-204-04
Identifier Type: -
Identifier Source: org_study_id
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