NCT04108351|Completed
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Sponsor study identifier
interventional
28
1 country
2
Study Start
October 7, 2019
Actual (reported)Primary Completion
February 11, 2020
Actual (reported)Study Completion
February 11, 2020
Actual (reported)The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 11, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2019
Actual (reported)September 30, 2019
Actual (reported)October 7, 2019
Actual (reported)February 11, 2020
Actual (reported)February 11, 2020
Actual (reported)Standard Deviation of Lateral Position (SDLP)
60 min
Distance Coefficient of Variation (DCV)
5 min
Brake Reaction Time (BRT)
5 min
Driving with simulator program for SDLP measurement
Intervention Description: Driving with simulator program for DCV measurement
Taisho Pharmaceutical Co., Ltd selected site
Fukuoka, Japan
The medical facility selected by Taisho Pharmaceutical Co., Ltd
Fukuoka, Japan
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.
Taisho Director
Taisho Pharmaceutical Co., Ltd.
28 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2019
First Posted
September 30, 2019
Study Start
October 7, 2019
Actual (reported)Driving with simulator program for BRT measurement
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
February 11, 2020
Actual (reported)Study Completion
February 11, 2020
Actual (reported)Last Updated
February 28, 2025
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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