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Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03278080
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to set an optimal measurement time for assessing driving ability in a driving simulator in healthy volunteers.

Condition or disease Intervention/treatment
Healthy Participants Other: Road-tracking test Other: Car-following test Other: Harsh-braking test

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of Assessment Method of Driving Ability Using Driving Simulator in Healthy Volunteers #1: Measurement Setup of Assessment Criteria for Driving Ability
Actual Study Start Date : September 22, 2017
Primary Completion Date : October 25, 2017
Study Completion Date : October 25, 2017
Arms and Interventions

Arm Intervention/treatment
driving test Other: Road-tracking test
Driving with simulator program for SDLP measurement
Other: Car-following test
Driving with simulator program for DCV measurement
Other: Harsh-braking test
Driving with simulator program for BRT measurement

Outcome Measures

Primary Outcome Measures :
  1. Standard Deviation of Lateral Position (SDLP) [ Time Frame: 60 min. ]

Secondary Outcome Measures :
  1. Distance Coefficient of Variation (DCV) [ Time Frame: 25 min. ]
  2. Brake Reaction Time (BRT) [ Time Frame: 15 min. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body mass index (BMI) ≥18.5 and <25.0 kg/m2 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
  • Routinely drink alcohol before bedtime
  • Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278080

Taisho Pharmaceutical Co., Ltd selected site
Fukuoka, Japan
Sponsors and Collaborators
Taisho Pharmaceutical Co., Ltd.
Nagoya University
Study Director: Shigeru Okuyama Taisho Pharmaceutical Co., Ltd.
More Information

Responsible Party: Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03278080     History of Changes
Other Study ID Numbers: DS-204-01
JapicCTI-173714 ( Other Identifier: JapicCTI )
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No