Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-26 @ 5:06 PM
Study NCT ID:
NCT05048069
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2021-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C052785', 'term': 'rebamipide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall clinical improvement', 'timeFrame': 'at 2 weeks of treatment', 'description': "Improved, No change, Worse The effective rate is defined as the percentage of subjects classified as 'Improved'."}, {'measure': 'the incidence rate and the number of cases for adverse events (AEs)', 'timeFrame': 'Safety information that occurred from the first administration to 3 days after discontinuation will be collected.'}], 'secondaryOutcomes': [{'measure': 'Endoscopic improvement rate', 'timeFrame': 'at baseline and 2 weeks', 'description': 'If upper GI endoscopy is performed at baseline and follow-up visits, the erosion score will be assessed and endoscopic improvement rate at 2 weeks will be evaluated. Endoscopic improvement rate is defined as ≥50% reduction of the erosion score.'}, {'measure': 'Gastric symptoms', 'timeFrame': 'at baseline and 2 weeks', 'description': 'Presence and type of gastric symptoms at baseline and 2 weeks will be collected.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Gastritis', 'Chronic Gastritis']}, 'descriptionModule': {'briefSummary': "This PMS is a non-interventional, prospective, single-arm, multi-center surveillance in accordance with Korean regulation, 'Standard for Re-Examination of New Drugs'. This PMS is to assess the safety and effectiveness after administrating Mucosta®SR Tab. Each subject would be observed for 2 weeks from baseline, if possible. As this PMS is an observational study in practical medical environment, the subject's follow-up is recommended but not obligatory and must be left up to the judgment of the investigator.", 'detailedDescription': 'According to the "Standards for Re-examination of New Drugs, etc." of South Korea, this PMS is conducted in order to collect safety and efficacy information for patients prescribed with Mucosta®SR Tab. under actual conditions of treatment during the re-examination period of Mucosta®SR Tab. 150mg (Rebamipide)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) in acute gastritis or acute exacerbation of chronic gastritis.\n2. Patients prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.\n3. Patients who have given a written informed consent to participation of this PMS and use of personal information after execution of the contract with the surveillance study site.\n\nExclusion Criteria:\n\n1. Patients with prior history of prescription with Mucosta®SR Tab.\n2. Patients with hypersensitivity to Rebamipide or its component ingredients.\n3. Patients deemed not suitable for surveillance enrollment according to investigator's medical judgment"}, 'identificationModule': {'nctId': 'NCT05048069', 'acronym': 'MCTSRPMS', 'briefTitle': 'Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': "Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab. in Korean Patients With Acute or Chronic Gastritis in Accordance With Korean Regulation, 'Standard for Re-examination of New Drugs'", 'orgStudyIdInfo': {'id': '037-402-00047'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mucosta®SR Tablets 150mg(Rebamipide)', 'type': 'DRUG', 'description': 'adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yumi An', 'role': 'CONTACT', 'email': 's3701@schmc.ac.kr', 'phone': '02-709-9222'}, {'name': 'Seongran Jeon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soon Chun Hyang University Hospital Seoul', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jisu Yang', 'role': 'CONTACT', 'email': 'js.yang@otsuka.co.kr', 'phone': '010-3188-9178'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}