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| Name | Class |
|---|---|
| Nagoya University | OTHER |
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The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zopiclone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Road-tracking test | Other | Driving with simulator program for SDLP measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard Deviation of Lateral Position (SDLP) | 60 min |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Coefficient of Variation (DCV) | 5 min | |
| Brake Reaction Time (BRT) | 5 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taisho Director | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taisho Pharmaceutical Co., Ltd selected site | Fukuoka | Japan | ||||
| The medical facility selected by Taisho Pharmaceutical Co., Ltd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32195934 | Derived | 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. |
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| Car-following test | Other | Intervention Description: Driving with simulator program for DCV measurement |
|
| Harsh-braking test | Other | Driving with simulator program for BRT measurement |
|
| Fukuoka |
| Japan |