Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone as a Positive Control

• Sponsor: Taisho Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04108351
• Collaborator: Nagoya University (Other)
• Enrollment: 28
• Locations: 2
• Arms: 2
• Actual Duration (Months): 4.2
• Patients Per Site: 14
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control

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: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone as a Positive Control
• Actual Study Start Date: Oct 7, 2019
• Actual Primary Completion Date: Feb 11, 2020
• Actual Study Completion Date: Feb 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zopiclone	Other: Road-tracking test; Driving with simulator program for SDLP measurement; Other: Car-following test; Intervention Description: Driving with simulator program for DCV measurement; Other: Harsh-braking test; Driving with simulator program for BRT measurement
Placebo Comparator: Placebo	Other: Road-tracking test; Driving with simulator program for SDLP measurement; Other: Car-following test; Intervention Description: 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) [5 min]

2. Brake Reaction Time (BRT) [5 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/m^2 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

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• History of drug and food allergy

• Hypersensitivity to zopiclone

• Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

• Other protocol defined inclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taisho Pharmaceutical Co., Ltd selected site	Fukuoka		Japan
2	The medical facility selected by Taisho Pharmaceutical Co., Ltd	Fukuoka		Japan

Sponsors and Collaborators

• Taisho Pharmaceutical Co., Ltd.
• Nagoya University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taisho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04108351
• Other Study ID Numbers: DS-204-04
• First Posted: Sep 30, 2019
• Last Update Posted: Feb 27, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypersensitivity

Study Results

No Results Posted as of Feb 27, 2020