Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-28 @ 5:39 PM
Study NCT ID:
NCT06974903
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2025-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Observational Study on GERD Management in General Hospitals in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-08', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Incidence of Adverse events following the administration of GERD treatment medications', 'timeFrame': 'From enrollment to 2 years and 7 months after registration', 'description': 'the safety assessment of all adverse events occurring after GERD medication treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GastroEsophageal Reflux Disease', 'GERD', 'Korean patients', 'Observational study', 'RetrospectiVe Observational study'], 'conditions': ['Gastroesophageal Reflux Disease (GERD)']}, 'descriptionModule': {'briefSummary': 'A RetrospectiVe ObservatIoNal Study of a CurrEnt Status and its Management of GERD (GastroEsophageal Reflux Disease) in General HOspitals in Korea', 'detailedDescription': "This study is designed as a multicenter, retrospective observational study. After signing a contract with the research institution or investigator, patients who meet the inclusion/exclusion criteria in the study protocol will be enrolled. The registration of patients at each research site will be carried out in order based on the most recent visit date (or GERD diagnosis date) as of January 1, 2018. Data from the study subjects will be collected by reviewing medical records from January 1, 2018, to August 31, 2020. These data will be recorded in the eCRF through interviews, examinations, and tests performed under the investigator's judgment during routine clinical practice within this period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Gastroesophageal Reflux Disease(GERD)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 19 years or older as of the date of their first visit.\n2. Patients who visited domestic general hospitals (secondary and tertiary healthcare institutions) at least twice between January 1, 2018, and August 31, 2020, for the diagnosis or treatment of GERD.\n\nExclusion Criteria:\n\n1. Patients with no GERD treatment information recorded in the medical records, even once.\n2. Patients deemed inappropriate for participation by the investigator (e.g., when the overall GERD diagnosis/treatment information is missing from the medical records).'}, 'identificationModule': {'nctId': 'NCT06974903', 'acronym': 'VINCERO', 'briefTitle': 'Retrospective Observational Study on GERD Management in General Hospitals in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A RetrospectiVe ObservatIoNal Study of a CurrEnt Status and Its Management of GERD (GastroEsophageal Reflux Disease) in General HOspitals in Korea', 'orgStudyIdInfo': {'id': 'D999_02GERD2003'}}, 'contactsLocationsModule': {'locations': [{'zip': '04763', 'city': 'Seoul', 'state': 'Seongdong-gu', 'country': 'South Korea', 'facility': 'Hanyang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}