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

February 26, 2025 updated by: Taisho Pharmaceutical Co., Ltd.
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • The medical facility selected by Taisho Pharmaceutical Co., Ltd
      • Fukuoka, Japan
        • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Standard Deviation of Lateral Position (SDLP)
Time Frame: 60 min
60 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Distance Coefficient of Variation (DCV)
Time Frame: 5 min
5 min
Brake Reaction Time (BRT)
Time Frame: 5 min
5 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taisho Pharmaceutical Co., Ltd.

Collaborators

Nagoya University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2019

Primary Completion (Actual)

February 11, 2020

Study Completion (Actual)

February 11, 2020

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS-204-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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