<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03278080</url>
  </required_header>
  <id_info>
    <org_study_id>DS-204-01</org_study_id>
    <secondary_id>JapicCTI-173714</secondary_id>
    <nct_id>NCT03278080</nct_id>
  </id_info>
  <brief_title>Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1</brief_title>
  <official_title>Development of Assessment Method of Driving Ability Using Driving Simulator in Healthy Volunteers #1: Measurement Setup of Assessment Criteria for Driving Ability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taisho Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nagoya University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taisho Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to set an optimal measurement time for assessing driving ability&#xD;
      in a driving simulator in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">October 25, 2017</completion_date>
  <primary_completion_date type="Actual">October 25, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Standard Deviation of Lateral Position (SDLP)</measure>
    <time_frame>60 min.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distance Coefficient of Variation (DCV)</measure>
    <time_frame>25 min.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brake Reaction Time (BRT)</measure>
    <time_frame>15 min.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>driving test</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Road-tracking test</intervention_name>
    <description>Driving with simulator program for SDLP measurement</description>
    <arm_group_label>driving test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Car-following test</intervention_name>
    <description>Driving with simulator program for DCV measurement</description>
    <arm_group_label>driving test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Harsh-braking test</intervention_name>
    <description>Driving with simulator program for BRT measurement</description>
    <arm_group_label>driving test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) ≥18.5 and &lt;25.0 kg/m2 at screening inspection&#xD;
&#xD;
          -  No visual impairment (enable to correct the vision with eyeglasses or contact lens)&#xD;
&#xD;
          -  Receive a prior explanation on the study, able to accept its content, and capable to&#xD;
             provide voluntary written consent for participation in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of drug and food allergy&#xD;
&#xD;
          -  Routinely drink alcohol before bedtime&#xD;
&#xD;
          -  Inappropriate for enrollment in this study was judged by principal investigator or&#xD;
             subinvestigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shigeru Okuyama</last_name>
    <role>Study Director</role>
    <affiliation>Taisho Pharmaceutical Co., Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taisho Pharmaceutical Co., Ltd selected site</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03278080
org study id: DS-204-01
secondary id: JapicCTI-173714
nct id: NCT03278080
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to set an optimal measurement time for assessing driving ability
      in a driving simulator in healthy volunteers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Standard Deviation of Lateral Position (SDLP)
time frame: 60 min.
measure: Distance Coefficient of Variation (DCV)
time frame: 25 min.
measure: Brake Reaction Time (BRT)
time frame: 15 min.
arm group label: driving test
arm group type: Other
intervention type: Other
intervention name: Road-tracking test
description: Driving with simulator program for SDLP measurement
arm group label: driving test
intervention type: Other
intervention name: Car-following test
description: Driving with simulator program for DCV measurement
arm group label: driving test
intervention type: Other
intervention name: Harsh-braking test
description: Driving with simulator program for BRT measurement
arm group label: driving test
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shigeru Okuyama
role: Study Director
affiliation: Taisho Pharmaceutical Co., Ltd.
facility: 
country: Japan
responsible party type: Sponsor