Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-30 @ 1:12 PM
Study NCT ID:
NCT05726734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-14
First Post:
2023-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C552956', 'term': '1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2026-02-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter pylori eradication rate', 'timeFrame': 'Six weeks after completion of therapy', 'description': 'Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\\<4‰) (4‰ as the cutoff value).'}], 'secondaryOutcomes': [{'measure': 'Rate of adverse effects', 'timeFrame': 'Within 7 days after completion of therapy', 'description': 'The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)'}, {'measure': 'Compliance rate', 'timeFrame': 'Within 7 days after completion of therapy', 'description': 'Compliance was defined as poor when they had taken less than 80% of the total medication'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter Pylori Infection'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'Vonoprazan Amoxicillin and metronidazole based triple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the Vonoprazan, amoxicillin and metronidazole based triple therapy and the empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with non-ulcer functional dyspepsia or peptic ulcer disease\n* Ability and willingness to participate in the study and to sign and give informed consent\n* Confirmed H. pylori infection and with no previous treatment experience\n\nExclusion Criteria:\n\n* Less than 18 years old\n* With previous gastric surgery\n* Major systemic diseases\n* Pregnancy or lactation\n* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion'}, 'identificationModule': {'nctId': 'NCT05726734', 'briefTitle': 'Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai East Hospital'}, 'officialTitle': 'Efficacy of Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2022150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vonoprazan-containing Triple Therapy', 'description': 'Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days', 'interventionNames': ['Drug: Vonoprazan', 'Drug: Amoxicillin, Metronidazole']}, {'type': 'EXPERIMENTAL', 'label': 'Empiric Bismuth Quadruple Therapy', 'description': 'Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days', 'interventionNames': ['Drug: Amoxicillin, Metronidazole', 'Drug: Bismuth Potassium Citrate', 'Drug: Esomeprazole']}], 'interventions': [{'name': 'Vonoprazan', 'type': 'DRUG', 'description': 'potassium-competitive acid blocker', 'armGroupLabels': ['Vonoprazan-containing Triple Therapy']}, {'name': 'Amoxicillin, Metronidazole', 'type': 'DRUG', 'description': 'Antibiotics for H. pylori eradication', 'armGroupLabels': ['Empiric Bismuth Quadruple Therapy', 'Vonoprazan-containing Triple Therapy']}, {'name': 'Bismuth Potassium Citrate', 'type': 'DRUG', 'description': 'Gastric mucosal protective drug with anti-H. pylori effect', 'armGroupLabels': ['Empiric Bismuth Quadruple Therapy']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'description': 'Proton pump inhibitor', 'armGroupLabels': ['Empiric Bismuth Quadruple Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200120', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Yingjie Ji, M.D.', 'role': 'CONTACT', 'email': 'jiyingjie39@outlook.com', 'phone': '86+15800575527'}, {'name': 'Qinwei Xu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xinyan Zhu', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shanghai East Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yingjie Ji, M.D.', 'role': 'CONTACT', 'email': 'jiyingjie39@outlook.com', 'phone': '+86-15800575527'}], 'overallOfficials': [{'name': 'Yingjie Ji, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai East Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai East Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital', 'investigatorFullName': 'Yingjie Ji', 'investigatorAffiliation': 'Shanghai East Hospital'}}}}