Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT04108351
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-09-26', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard Deviation of Lateral Position (SDLP)', 'timeFrame': '60 min'}], 'secondaryOutcomes': [{'measure': 'Distance Coefficient of Variation (DCV)', 'timeFrame': '5 min'}, {'measure': 'Brake Reaction Time (BRT)', 'timeFrame': '5 min'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'referencesModule': {'references': [{'pmid': '32195934', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) ≥18.5 and \\<25.0 kg/m\\^2 at screening inspection\n* No visual impairment (enable to correct the vision with eyeglasses or contact lens)\n* Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* History of drug and food allergy\n* Hypersensitivity to zopiclone\n* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator\n* Other protocol defined inclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT04108351', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taisho Pharmaceutical Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'DS-204-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zopiclone', 'interventionNames': ['Other: Road-tracking test', 'Other: Car-following test', 'Other: Harsh-braking test']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Road-tracking test', 'Other: Car-following test', 'Other: Harsh-braking test']}], 'interventions': [{'name': 'Road-tracking test', 'type': 'OTHER', 'description': 'Driving with simulator program for SDLP measurement', 'armGroupLabels': ['Placebo', 'Zopiclone']}, {'name': 'Car-following test', 'type': 'OTHER', 'description': 'Intervention Description: Driving with simulator program for DCV measurement', 'armGroupLabels': ['Placebo', 'Zopiclone']}, {'name': 'Harsh-braking test', 'type': 'OTHER', 'description': 'Driving with simulator program for BRT measurement', 'armGroupLabels': ['Placebo', 'Zopiclone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Taisho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'The medical facility selected by Taisho Pharmaceutical Co., Ltd', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'Taisho Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taisho Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taisho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Nagoya University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}