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

October 4, 2022 updated by: Taisho Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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

  • Japan
      • 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

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

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Driving with simulator program for SDLP measurement
Other: Harsh-braking test
Driving with simulator program for BRT measurement
Other: Car-following test
Driving with simulator program for DCV measurement
Other: BAC level 0.05 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%
Other: Road-tracking test
Driving with simulator program for SDLP measurement
Other: Harsh-braking test
Driving with simulator program for BRT measurement
Other: Car-following test
Driving with simulator program for DCV measurement
Other: BAC level 0.09 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%
Other: Road-tracking test
Driving with simulator program for SDLP measurement
Other: Harsh-braking test
Driving with simulator program for BRT measurement
Other: Car-following test
Driving with simulator program for DCV measurement
Other: BAC level 0 %
Drink beverages containing non alcohol
Other: Road-tracking test
Driving with simulator program for SDLP measurement
Other: Harsh-braking test
Driving with simulator program for BRT measurement
Other: Car-following test
Driving with simulator program for DCV 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

Taisho Pharmaceutical Co., Ltd.

Collaborators

Nagoya University

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.

General Publications

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)

June 27, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • DS-204-03
  • JapicCTI-184006 (Other Identifier: JapicCTI)

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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