Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT06668506
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005756', 'term': 'Gastritis'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2814}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total subjective symptom score compared to baseline', 'timeFrame': '2 weeks (up to 4 weeks)', 'description': 'Change in total subjective symptom score compared to baseline at 2 weeks (up to 4 weeks) on a scale of 0 to 3 points for 8 items (epigastric pain, severe pain, nausea/vomiting, acid reflux, bloating, poor appetite, heartburn, burping). Higher scores are indicative of more severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in individual subjective symptom score compared to baseline', 'timeFrame': '2 weeks (maximum 4 weeks)', 'description': 'Change in individual subjective symptom score compared to baseline at 2 weeks (up to 4 weeks) on a scale of 0 to 3 points for 8 items (epigastric pain, severe pain, nausea/vomiting, acid reflux, bloating, poor appetite, heartburn, burping). Higher scores are indicative of more severe symptoms.'}, {'measure': 'The effective rate of subjective symptoms compared to baseline', 'timeFrame': '2 weeks (maximum 4 weeks)', 'description': 'The effective rate of subjective symptoms compared to baseline at 2 weeks (maximum 4 weeks). The effective rate is the percentage of patients whose total subjective symptom scores are reduced by more than 50% compared to their scores before administration.'}, {'measure': 'Overall change assessed by study subjects after administration of the study drug', 'timeFrame': '2 weeks (maximum 4 weeks)', 'description': 'Overall change assessed by study subjects after administration of the study drug at 2 weeks. (maximum 4 weeks) The overall change is assessed using five criteria: very much improved, much improved, minimally improved, no change, and worse.'}, {'measure': 'Overall change assessed by the researcher after administration of the drug under study', 'timeFrame': '2 weeks (maximum 4 weeks)', 'description': 'Overall change assessed by the researcher after administration of the drug under study at 2 weeks (maximum 4 weeks). The overall change is assessed using five criteria: very much improved, much improved, minimally improved, no change, and worse.'}, {'measure': 'Adverse events that occurred after administration of Mucotra® extended-release tablets', 'timeFrame': '2 weeks (maximum 4 weeks)', 'description': 'Adverse events that occurred after administration of Mucotra® extended-release tablets at 2 weeks (maximum 4 weeks)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastritis']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the improvement effect on subjective symptoms of gastritis and adverse events through patient self-assessment results (PRO) by conducting follow-up observations for patients with gastritis at 2 to 4 weeks after administration of Mucotra® SR tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The minimum number of study subjects required to estimate the two-sided 95% confidence interval of the change in the total score of subjective symptoms at 2 weeks compared to the baseline as -3.19 to 2.99, with the standard deviation assumed by referring to the AD-203P3 literature, is calculated to be 15,247 ( PASS 13. NCSS, LLC. (Kailsville, Utah, USA)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged ≥ 19 years\n* Subjects with acute or chronic gastritis, requiring treatment with Mucotra® SR tab\n* Subjects with subjective symptoms\n* Subjects who voluntarily consent to participate in this observational study\n\nExclusion Criteria:\n\n* Subjects who have had a hypersensitivity reaction to the components of Mucotra® SR tab\n* Subject with genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption'}, 'identificationModule': {'nctId': 'NCT06668506', 'briefTitle': 'To Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Multi-center, Prospective, Observational Study to Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis', 'orgStudyIdInfo': {'id': 'MUC0S_OS_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mucotra® SR Tab', 'description': 'Mucotra® SR Tab Rebamipide 150mg'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Song Kwang Seon Internal medicine clinic', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}