Back to resultsDevelopment and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone as a Positive Control
Primary Purpose
Healthy Participants
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Road-tracking test
Car-following test
Harsh-braking test
Sponsored by
About this trial
This is an interventional other trial for Healthy Participants
Eligibility Criteria
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
Sites / Locations
- Taisho Pharmaceutical Co., Ltd selected site
- The medical facility selected by Taisho Pharmaceutical Co., Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Zopiclone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Standard Deviation of Lateral Position (SDLP)
Secondary Outcome Measures
Distance Coefficient of Variation (DCV)
Brake Reaction Time (BRT)
Full Information
NCT ID
NCT04108351
First Posted
September 26, 2019
Last Updated
October 4, 2022
Sponsor
Taisho Pharmaceutical Co., Ltd.
Collaborators
Nagoya University
1. Study Identification
Unique Protocol Identification Number
NCT04108351
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
February 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taisho Pharmaceutical Co., Ltd.
Collaborators
Nagoya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zopiclone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Road-tracking test
Intervention Description
Driving with simulator program for SDLP measurement
Intervention Type
Other
Intervention Name(s)
Car-following test
Intervention Description
Intervention Description: Driving with simulator program for DCV measurement
Intervention Type
Other
Intervention Name(s)
Harsh-braking test
Intervention Description
Driving with simulator program for BRT measurement
Primary Outcome Measure Information:
Title
Standard Deviation of Lateral Position (SDLP)
Time Frame
60 min
Secondary Outcome Measure Information:
Title
Distance Coefficient of Variation (DCV)
Time Frame
5 min
Title
Brake Reaction Time (BRT)
Time Frame
5 min
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taisho Director
Organizational Affiliation
Taisho Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Taisho Pharmaceutical Co., Ltd selected site
City
Fukuoka
Country
Japan
Facility Name
The medical facility selected by Taisho Pharmaceutical Co., Ltd
City
Fukuoka
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32195934
Citation
Iwata M, Iwamoto K, Kambe D, Tachibana N, Ando M, Ozaki N. 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: Study Protocol Clinical Trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Mar;99(12):e19395. doi: 10.1097/MD.0000000000019395.
Results Reference
derived
Learn more about this trial
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
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