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CompletedNCT03572985Updated Feb 28, 2025

Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3

An interventional study of Road-tracking test and Car-following test in Healthy Participants, sponsored by Taisho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 21 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Taisho Pharmaceutical Co., Ltd. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
21 Years to 64 Years
Sex
Male
01

Study summary

The purpose of this study is to collect alcohol calibration data for the driving simulator.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Taisho Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 4 are open to participants now.

Browse Taisho Pharmaceutical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 64 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Other
    Blood alcohol concentration (BAC) level 0.025 %

    Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025%

    Other: Road-tracking test · Other: Car-following test · Other: Harsh-braking test

  • Other
    BAC level 0.05 %

    Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%

    Other: Road-tracking test · Other: Car-following test · Other: Harsh-braking test

  • Other
    BAC level 0.09 %

    Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%

    Other: Road-tracking test · Other: Car-following test · Other: Harsh-braking test

  • Other
    BAC level 0 %

    Drink beverages containing non alcohol

    Other: Road-tracking test · Other: Car-following test · Other: Harsh-braking test

Interventions

  • OtherRoad-tracking test

    Driving with simulator program for SDLP measurement

  • OtherCar-following test

    Driving with simulator program for DCV measurement

  • OtherHarsh-braking test

    Driving with simulator program for BRT measurement

06

What researchers measure

Primary outcomes

  1. Standard Deviation of Lateral Position (SDLP)

    Time frame: 60 min

Secondary outcomes

  1. Distance Coefficient of Variation (DCV)

    Time frame: 5 min

  2. Brake Reaction Time (BRT)

    Time frame: 5 min

07

Study locations

1 site
  • Taisho Pharmaceutical Co., Ltd selected site
    Fukuoka, Japan
08

References and documents

Publications

  • 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. PubMed 30813188 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03572985
Lead sponsor
Taisho Pharmaceutical Co., Ltd.
Collaborators
Nagoya University
Responsible party
Sponsor
First posted
Jun 28, 2018
Start date
Jun 27, 2018
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019
Last update
Feb 28, 2025

Study contacts

Shigeru Okuyama
study director · Taisho Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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