NCT03413592

Completed

Development of Assessment Method for Driving Ability Using D...

Taisho Pharmaceutical Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

DS-204-02

Secondary identifiers

JapicCTI-183832

OTHER · JapicCTI

Study Type

interventional

Actual enrollment (reported)

20

Locations

1 country

Sites

1

Timeline

Study Start

January 22, 2018

Actual (reported)

Primary Completion

April 30, 2018

Actual (reported)

Study Completion

April 30, 2018

Actual (reported)

Brief Summary

The purpose of this study is to verify the intra-individual difference of the SDLP values in driving simulator.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 20 participants
Study completion date: April 30, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 16, 2018
Actual (reported)
Study Start
January 22, 2018
Actual (reported)
First Posted
January 29, 2018
Actual (reported)
Primary Completion
April 30, 2018
Actual (reported)
Study Completion
April 30, 2018
Actual (reported)

Last Updated: February 28, 2025
Status Verified: July 2018
Last Update Submitted: February 26, 2025

Conditions

Healthy Participants

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 (1)

Driving test

OTHER

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

Interventions

Road-tracking testOther

Driving with simulator program for SDLP measurement

Driving test

Car-following testOther

Driving with simulator program for DCV measurement

Driving test

Eligibility Criteria

Age21 Years - 64 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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)

Sponsors & Collaborators

Nagoya University
Othercollaborator
Taisho Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Fukuoka, Japan

Study Officials

Shigeru Okuyama
Taisho Pharmaceutical Co., Ltd.
STUDY DIRECTOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 29, 2018

Study Start

January 22, 2018

Actual (reported)

Completed

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Harsh-braking testOther

Driving with simulator program for BRT measurement

Driving test

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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
Routinely drink alcohol before bedtime
Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Contact the study team to confirm eligibility.

Primary Completion

April 30, 2018

Actual (reported)

Study Completion

April 30, 2018

Actual (reported)

Last Updated

February 28, 2025

Record last verified: 2018-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03413592
Data provider: ClinicalTrials.gov
Source updated: 2025-02-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:06 UTC

Locations

JP(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Driving test

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations