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

• Sponsor: Taisho Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03278080
• Collaborator: Nagoya University (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 18.4

Study Details

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	Phase
Healthy Participants	Other: Road-tracking test; Other: Car-following test; Other: Harsh-braking test	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• 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: Sep 22, 2017
• Actual Primary Completion Date: Oct 25, 2017
• Actual Study Completion Date: Oct 25, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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) [60 min.]

Secondary Outcome Measures

1. Distance Coefficient of Variation (DCV) [25 min.]

2. Brake Reaction Time (BRT) [15 min.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 64 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Taisho Pharmaceutical Co., Ltd selected site	Fukuoka		Japan

Sponsors and Collaborators

• Taisho Pharmaceutical Co., Ltd.
• Nagoya University

Investigators

• Study Director: Shigeru Okuyama, Taisho Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taisho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03278080
• Other Study ID Numbers: DS-204-01; JapicCTI-173714
• First Posted: Sep 11, 2017
• Last Update Posted: Jan 17, 2018
• Last Verified: Oct 1, 2017

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

Study Results

No Results Posted as of Jan 17, 2018