Healthy ParticipantsNCT03413592

Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2

A study testing Road-tracking test, Car-following test and Harsh-braking test in people with Healthy Participants, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to verify the intra-individual difference of the SDLP values in driving simulator. Read more about this study

Who is it for?: Ages 21 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Road-tracking test, Car-following test and Harsh-braking test
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteJapan
Study dates: 22 Jan 2018to 30 Apr 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 64 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index (BMI) ≥18.5 and <25.0 kg/m2 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

Who cannot join

History of drug and food allergy
Routinely drink alcohol before bedtime
Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Trial locations and contacts

1 site in 1 country.

Japan1 site

Taisho Pharmaceutical Co., Ltd selected site
Fukuoka

Other trials in Japan

About this study

Official title: Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2: Verification of Intra-individual Difference

The purpose of this study is to verify the intra-individual difference of the SDLP values in driving simulator.

Conditions: Healthy Participants
Being tested: Road-tracking test, Car-following test, Harsh-braking test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Road-tracking testOther
Driving with simulator program for SDLP measurement
Car-following testOther
Driving with simulator program for DCV measurement
Harsh-braking testOther
Driving with simulator program for BRT measurement

Study groups in NCT03413592
Study group	Role	What they receive
Driving test	Other	Not described Receives: Other: Road-tracking test; Other: Car-following test; Other: Harsh-braking test

What is being measured

The primary outcome is the main question the study is designed to answer.

Standard Deviation of Lateral Position (SDLP)
Measured: 60 min

Secondary outcomes (2)

Distance Coefficient of Variation (DCV)
Measured: 5 min
Brake Reaction Time (BRT)
Measured: 5 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 201830 Apr 2018

First posted29 Jan 2018
Study start22 Jan 2018
Primary completion30 Apr 2018
Study completion30 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03413592
Sponsor's protocol ID: DS-204-02
Other IDs: JapicCTI-183832
Status last verified: Jul 2018
First submitted: 16 Jan 2018
Last updated: 28 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2: Verification of Intra-individual Difference
ClinicalTrials.gov ID: NCT03413592
Acronym / sponsor ID: DS-204-02
Conditions: Healthy Participants
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Nagoya University
Study start: 22 Jan 2018 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 29 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to verify the intra-individual difference of the SDLP values in driving simulator.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Driving test	Other	Other: Road-tracking test, Other: Car-following test, Other: Harsh-braking test

Who may qualify

Ages: 21 to 64 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Body mass index (BMI) ≥18.5 and <25.0 kg/m2 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

Key exclusion criteria (3 listed)

History of drug and food allergy
Routinely drink alcohol before bedtime
Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Road-tracking testDriving with simulator program for SDLP measurement	Other	Driving test
Car-following testDriving with simulator program for DCV measurement	Other	Driving test
Harsh-braking testDriving with simulator program for BRT measurement	Other	Driving test

Primary outcome

Standard Deviation of Lateral Position (SDLP)
Time frame: 60 min

2 secondary outcomes

Distance Coefficient of Variation (DCV)
Time frame: 5 min
Brake Reaction Time (BRT)
Time frame: 5 min

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Individual participant dataSharing planned: No

Related trials for Healthy Participants

Active, not recruitingPhase 1/2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shigeru Okuyama study director

Taisho Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Road-tracking test, Car-following test and Harsh-braking test in people with Healthy Participants, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standard Deviation of Lateral Position (SDLP) (time frame: 60 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03413592.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.