Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-06 @ 11:46 AM
Study NCT ID:
NCT05453994
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bismuth for PCAB-based H. Pylori Eradication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2022-07-07', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H. pylori infection status', 'timeFrame': '6 weeks', 'description': 'Rate of successful H. pylori eradication'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['H. Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '38459869', 'type': 'DERIVED', 'citation': 'Cho JH. Bismuth add-on improves the efficacy of 2-week tegoprazan-based triple therapy for first-line Helicobacter pylori eradication: a real-world evidence study. Expert Rev Anti Infect Ther. 2024 Sep;22(9):793-799. doi: 10.1080/14787210.2024.2329251. Epub 2024 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'Tegoprazan is a new potassium-competitive acid blocker (PCAB) that has been clinically available since 2018 in South Korea. P-CAB is highly active drugs targeting H+, K+ -ATPase in the gastric acid secretion of parietal cells. The mechanism of action is different from that of PPIs. Conventional PPIs require 3-5 days to achieve maximal and steady-state gastric acid inhibition, whereas P-CAB increases the intragastric pH to nearly 7 within four hours. In Japan, H. pylori eradication success rates has increased by therapies using P-CAB than those using proton pump inhibitors, owing to the stronger acid suppression capability of P-CAB.\n\nBismuth has long been used to treat peptic ulcer disease, dyspepsia, parasite infections, and infectious diarrhea. The antibacterial effects of bismuth include inhibition of protein and cell wall synthesis in H. pylori. The main role of bismuth is to increase the eradication rate by 30%-40% in resistant H. pylori strains.', 'detailedDescription': 'The investigators aim to evaluate the success rate and adverse drug events of bismuth added to PCAB-based triple therapy as a first-line regimen for H. pylori infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'H. pylori-infected patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastroscopy can be performed\n* H. pylori test and pathological analysis can be performed\n\nExclusion Criteria:\n\n* Age \\< 20 or \\> 80 years\n* Anemia (serum hemoglobin level \\< 10 g/dL)\n* Severe systemic disease\n* Advanced chronic liver disease\n* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics\n* History of H. pylori eradication\n* Drug allergy to antibiotics\n* History of gastric surgery\n* Recent history of upper gastrointestinal bleeding'}, 'identificationModule': {'nctId': 'NCT05453994', 'briefTitle': 'Bismuth for PCAB-based H. Pylori Eradication', 'organization': {'class': 'OTHER', 'fullName': 'Soonchunhyang University Hospital'}, 'officialTitle': 'Efficacy of Bismuth Added to Potassium-competitive Acid Blocker-based Triple Regimen for First-line Helicobacter Pylori Eradication', 'orgStudyIdInfo': {'id': 'SCH-HP-2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-bismuth group', 'description': 'Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid for 14 days', 'interventionNames': ['Drug: H. pylori eradication']}, {'label': 'Bismuth group', 'description': 'Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days', 'interventionNames': ['Drug: H. pylori eradication']}], 'interventions': [{'name': 'H. pylori eradication', 'type': 'DRUG', 'description': 'PPIs-based Antimicrobial agents for H. pylori eradication', 'armGroupLabels': ['Bismuth group', 'Non-bismuth group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Digestive Disease Center, Soonchunhyang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jun-Hyung Cho, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jun-Hyung Cho', 'investigatorAffiliation': 'Soonchunhyang University Hospital'}}}}