NCT03413592

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

February 28, 2025

Status Verified

July 1, 2018

Enrollment Period

3 months

First QC Date

January 16, 2018

Last Update Submit

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
Harsh-braking testOTHER

Driving with simulator program for BRT 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)
  • 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.

Sponsors & Collaborators

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Fukuoka, Japan

Location

Study Officials

  • Shigeru Okuyama

    Taisho Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

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

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

February 28, 2025

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)