Healthy ParticipantsNCT04108351
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
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 2 sites in Japan.
Trial summary
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control 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?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesJapan
- Study dates
- 7 Oct 2019to 11 Feb 2020
- 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/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
- Other protocol defined inclusion criteria could apply
Who cannot join
- History of drug and food allergy
- Hypersensitivity to zopiclone
- Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
- Other protocol defined inclusion criteria could apply
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Taisho Pharmaceutical Co., Ltd selected site
Fukuoka
The medical facility selected by Taisho Pharmaceutical Co., Ltd
Fukuoka
About this study
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
- 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
Intervention Description: Driving with simulator program for DCV measurement
Harsh-braking testOther
Driving with simulator program for BRT measurement
| Study group | Role | What they receive |
|---|---|---|
| Zopiclone | Experimental | Not described Receives: Other: Road-tracking test; Other: Car-following test; Other: Harsh-braking test |
| Placebo | Placebo comparator | 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.
- First posted30 Sep 2019
- Study start7 Oct 2019
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nagoya University
- Responsible party
- Sponsor
- Investigators
- Taisho Director, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108351
- Sponsor's protocol ID
- DS-204-04
- Status last verified
- Feb 2020
- First submitted
- 26 Sep 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32195934
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 and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone As a Positive Control
- ClinicalTrials.gov ID
- NCT04108351
- Acronym / sponsor ID
- DS-204-04
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nagoya University
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 30 Sep 2019 (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 confirm of assay sensitivity of Driving Simulator by positive control
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zopiclone | Experimental | Other: Road-tracking test, Other: Car-following test, Other: Harsh-braking test |
| Placebo | Placebo comparator | 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 (4 listed)
- 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
- Other protocol defined inclusion criteria could apply
Key exclusion criteria (4 listed)
- History of drug and food allergy
- Hypersensitivity to zopiclone
- Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
- Other protocol defined inclusion criteria could apply
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 | Placebo, Zopiclone |
| Car-following testIntervention Description: Driving with simulator program for DCV measurement | Other | Placebo, Zopiclone |
| Harsh-braking testDriving with simulator program for BRT measurement | Other | Placebo, Zopiclone |
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.
- Derived from this study: PubMed 32195934Iwata 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.
- Individual participant dataSharing planned: No
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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.
Taisho Director study director
Taisho Pharmaceutical Co., Ltd.
2 sites 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 2 sites 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 4 inclusion and 4 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 2 sites 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. Some participants in this study may receive a placebo. 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 NCT04108351, which also lists 1 linked publication.
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.