Development of Assessment Method for Driving Ability Usin... | NCT03278080

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

NCT03278080

Sponsor

Taisho Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Feb 28, 2025Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy Participants

Interventions

Road-tracking test
Car-following test
Harsh-braking test

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
JapicCTI-173714	Other Identifier	JapicCTI

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2017Actual

Primary Completion Date

Oct 25, 2017Actual

Completion Date

Oct 25, 2017Actual

First Submitted Date

Sep 8, 2017

First Submission Date that Met QC Criteria

Sep 8, 2017

First Posted Date

Sep 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2025

Last Update Posted Date

Feb 28, 2025Actual

Name	Class
Nagoya University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
driving test	Other		Other: Road-tracking test Other: Car-following test Other: Harsh-braking test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Road-tracking test	Other	Driving with simulator program for SDLP measurement	driving test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standard Deviation of Lateral Position (SDLP)		60 min.

Secondary Outcomes

Measure	Description	Time Frame
Distance Coefficient of Variation (DCV)		25 min.
Brake Reaction Time (BRT)		15 min.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shigeru Okuyama	Taisho Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taisho Pharmaceutical Co., Ltd selected site		Fukuoka			Japan