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
1 other identifier
interventional
28
1 country
2
Brief Summary
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
2 active sites
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
September 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 30, 2019
CompletedStudy Start
First participant enrolled
October 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2020
CompletedFebruary 28, 2025
February 1, 2020
4 months
September 26, 2019
February 26, 2025
Conditions
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 (2)
Zopiclone
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Intervention Description: Driving with simulator program for DCV measurement
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of drug and food allergy
- Hypersensitivity to zopiclone
- Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taisho Pharmaceutical Co., Ltd.lead
- Nagoya Universitycollaborator
Study Sites (2)
Taisho Pharmaceutical Co., Ltd selected site
Fukuoka, Japan
The medical facility selected by Taisho Pharmaceutical Co., Ltd
Fukuoka, Japan
Related Publications (1)
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.
PMID: 32195934DERIVED
Study Officials
- STUDY DIRECTOR
Taisho Director
Taisho Pharmaceutical Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2019
First Posted
September 30, 2019
Study Start
October 7, 2019
Primary Completion
February 11, 2020
Study Completion
February 11, 2020
Last Updated
February 28, 2025
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share