Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-21 @ 8:40 AM
Study NCT ID:
NCT02557932
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2015-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 352}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2015-09-21', 'studyFirstSubmitQcDate': '2015-09-21', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H. pylori eradication rate', 'timeFrame': '8 weeks after H. pylori treatment'}], 'secondaryOutcomes': [{'measure': 'Complications of H. pylori treatment', 'timeFrame': '1 month after H. pylori treatment'}, {'measure': 'Compliance to H. pylori treatment', 'timeFrame': '1 month'}, {'measure': 'H. pylori infection status at 1 year after H. pylori treatment', 'timeFrame': '1 year after H. pylori treatment'}, {'measure': 'H. pylori reinfection rate', 'timeFrame': '3 years after success of H. pylori eradication'}, {'measure': 'Factors associated with H. pylori reinfection', 'timeFrame': '3 years after success of H. pylori treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PPI standard triple therapy', 'Bismuth quadruple therapy', 'Helicobacter'], 'conditions': ['Helicobacter Pylori Infection', 'Family History of Stomach Cancer']}, 'referencesModule': {'references': [{'pmid': '33653284', 'type': 'DERIVED', 'citation': 'Kim YI, Lee JY, Kim CG, Park B, Park JY, Choi IJ. Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial. BMC Gastroenterol. 2021 Mar 2;21(1):95. doi: 10.1186/s12876-021-01680-1.'}]}, 'descriptionModule': {'briefSummary': 'In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.', 'detailedDescription': 'Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged 18 or more including following conditions\n\n * Family history of gastric cancer\n * Post endoscopic resection status for early gastric cancer or adenoma\n * Peptic ulcer disease (benign gastric ulcer and duodenal ulcer)\n * Chronic gastritis\n * Non-ulcer dyspepsia\n * Healthy adults who want to receive H. pylori treatment\n* H. pylori positive by urea breath test, histology, or rapid urease test\n\nExclusion Criteria:\n\n* History of H. pylori eradication therapy\n* History of stomach operation\n* Other organ cancer within 5 years\n* Liver cirrhosis or Hepatic insufficiency\n* Renal insufficiency\n* Current treatment for serious medical condition which may hinder participation\n* Contraindication or allergy history for H. pylori treatment regimens\n* Mental incompetence to understand and sign informed consent\n* Incompatible conditions to be included into the trial by investigators' decision\n* Inability to provide an informed consent\n* History of treatment for peptic ulcer disease"}, 'identificationModule': {'nctId': 'NCT02557932', 'briefTitle': 'Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Comparison of 7-day Proton Pump Inhibitor (PPI)-Clarithromycin Containing Triple Therapy and 10-day Bismuth Quadruple Therapy for Helicobacter Eradication as First-line Regimen: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NCC2015-0207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard triple therapy', 'description': '7 day-PPI based standard triple therapy', 'interventionNames': ['Drug: Standard triple therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bismuth quadruple therapy', 'description': '10 day-bismuth quadruple therapy', 'interventionNames': ['Drug: Bismuth quadruple therapy']}], 'interventions': [{'name': 'Standard triple therapy', 'type': 'DRUG', 'otherNames': ['7-day PPI-based standard triple therapy'], 'description': 'Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days', 'armGroupLabels': ['Standard triple therapy']}, {'name': 'Bismuth quadruple therapy', 'type': 'DRUG', 'otherNames': ['10-day Bismuth quadruple therapy'], 'description': 'Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days', 'armGroupLabels': ['Bismuth quadruple therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10408', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'overallOfficials': [{'name': 'Il Ju Choi, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of gastroenterology, Center for Gastric Cancer', 'investigatorFullName': 'Il Ju Choi', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}