Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3
2 other identifiers
interventional
25
1 country
1
Brief Summary
The purpose of this study is to collect alcohol calibration data for the driving simulator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2018
CompletedStudy Start
First participant enrolled
June 27, 2018
CompletedFirst Posted
Study publicly available on registry
June 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedFebruary 28, 2025
November 1, 2019
7 months
June 19, 2018
February 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Standard Deviation of Lateral Position (SDLP)
60 min
Secondary Outcomes (2)
Distance Coefficient of Variation (DCV)
5 min
Brake Reaction Time (BRT)
5 min
Study Arms (4)
Blood alcohol concentration (BAC) level 0.025 %
OTHERDrink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025%
BAC level 0.05 %
OTHERDrink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%
BAC level 0.09 %
OTHERDrink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%
BAC level 0 %
OTHERDrink beverages containing non alcohol
Interventions
Driving with simulator program for SDLP measurement
Driving with simulator program for DCV measurement
Driving with simulator program for BRT measurement
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of drug and food allergy
- Alcohol dependence, drug dependence or abnormal drunken (including past history)
- Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taisho Pharmaceutical Co., Ltd.lead
- Nagoya Universitycollaborator
Study Sites (1)
Taisho Pharmaceutical Co., Ltd selected site
Fukuoka, Japan
Related Publications (1)
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.
PMID: 30813188DERIVED
Study Officials
- STUDY DIRECTOR
Shigeru Okuyama
Taisho Pharmaceutical Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2018
First Posted
June 28, 2018
Study Start
June 27, 2018
Primary Completion
January 31, 2019
Study Completion
January 31, 2019
Last Updated
February 28, 2025
Record last verified: 2019-11