Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04189705
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2019-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 392}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2019-11-25', 'studyFirstSubmitQcDate': '2019-12-04', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoscopic Improvement Rate', 'timeFrame': '2 weeks', 'description': 'The percentage of subjects with improvement refer to those with more than 50% improvement in erosion score on gastroscopy after treatment compared to the score before treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Gastritis', 'Chronic Gastritis']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double-blind, active-controlled, non-inferiority, phase 3 study to evaluate the efficacy and safety of MCT-SR in patients with gastritis.', 'detailedDescription': 'To contribute greater treatment compliance and patient convenience, the rebamipide SR formulation has been developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males and females aged ≥19 and \\<75 years\n* Patients diagnosed with acute or chronic gastritis by gastroscopy with at least 1 erosion confirmed by gastroscopy within 7 days prior to the first dose of the Investigational Product(IP)\n\nExclusion Criteria:\n\n* Patients ineligible for gastroscopy\n* Patients who took other drugs for treating gastritis within 2 weeks prior to the first dose of the IP.\n* Patients who have to continue taking drugs that may induce gastritis\n* Other clinically significant medical or psychiatric findings that the investigator considers inappropriate for the study'}, 'identificationModule': {'nctId': 'NCT04189705', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Active-controlled, Non-inferiority, Phase 3 Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis', 'orgStudyIdInfo': {'id': '037-402-00039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCT-SR', 'description': 'Drug: MCT-SR 2 times/day for 2 weeks', 'interventionNames': ['Drug: MCT-SR', 'Drug: Mucosta Tab.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mucosta Tab.', 'description': 'Drug: Mucosta Tab. 3 times/day for 2 weeks', 'interventionNames': ['Drug: MCT-SR', 'Drug: Mucosta Tab.']}], 'interventions': [{'name': 'MCT-SR', 'type': 'DRUG', 'description': 'Rebamipide 150mg', 'armGroupLabels': ['MCT-SR', 'Mucosta Tab.']}, {'name': 'Mucosta Tab.', 'type': 'DRUG', 'otherNames': ['Mucosta'], 'description': 'Rebamipide 100mg', 'armGroupLabels': ['MCT-SR', 'Mucosta Tab.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'JaeGyu Kim, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}