Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-01 @ 4:48 PM
Study NCT ID:
NCT05152004
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2021-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacies of Hybrid and High-dose Dual Therapies for the First-line Anti-H Pylori Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064750', 'term': 'Rabeprazole'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional Study Model'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2021-11-28', 'studyFirstSubmitQcDate': '2021-11-28', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rates of H.pylori eradication', 'timeFrame': '4-8 weeks', 'description': "The primary outcome variables were the rates of eradication. Chi-square test with or without Yates correction for continuity and Fisher's exact test were used when appropriate to compare the major outcomes between groups. A P value less than 0.05 was considered statistically significant."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori eradication', 'Hybrid therapy', 'High dose dual proton pump inhibitor and Amoxicillin therapy'], 'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '37133673', 'type': 'DERIVED', 'citation': 'Tai WC, Yang SC, Yao CC, Wu CK, Liu AC, Lee CH, Kuo YH, Chuah SK, Liang CM. The Efficacy and Safety of 14-day Rabeprazole Plus Amoxicillin High Dose Dual Therapy by Comparing to 14-day Rabeprazole-Containing Hybrid Therapy for the Naive Helicobacter pylori Infection in Taiwan: A Randomized Controlled Trial. Infect Dis Ther. 2023 May;12(5):1415-1427. doi: 10.1007/s40121-023-00811-3. Epub 2023 May 3.'}]}, 'descriptionModule': {'briefSummary': 'Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection. This study aims to better understand the potential of both hybrid and igh-dose dual therapies in the treatment of H. pylori infection.\n\n.', 'detailedDescription': 'Helicobacter pylori (H. pylori) infect more than 50% of humans globally. It is the principal cause of chronic gastritis, gastric ulcer, duodenal ulcer, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma (MALToma). The Real-world Practice \\& Expectation of Asia-Pacific Physicians and Patients in H. pylori Eradication (REAP-HP) Survey demonstrated that standard triple therapy was still the most commonly used anti-H. pylori regimen in the Asia Pacific region. However, the eradication rates of standard triple therapy have declined to less than 80% in most countries worldwide. The main reasons for eradication failure of standard triple therapy include antibiotic resistance, poor compliance and CYP2C19 genotype of host. Clarithromycin resistance of H. pylori has been identified as the main reason for the failure of standard triple therapy. Pooled data from 20 studies involving 1,975 patients treated with standard triple therapy showed an eradication rate of 88% in clarithromycin-sensitive strains versus 18% in clarithromycin-resistant strains. Therefore, the background rate of clarithromycin resistance is critically important for the efficacy of standard triple therapy. Recently, several strategies including bismuth-containing quadruple therapy, non-bismuth quadruple therapy (i.e., sequential therapy, concomitant therapy and hybrid therapy) and high-dose dual therapy have been proposed to increase the eradication rate.\n\nHybrid therapy developed by our study group in 2011 consists of a dual therapy with a proton pump inhibitor (PPI) and amoxicillin for 7 days followed by a quadruple regimen with a PPI, amoxicillin, clarithromycin and metronidazole for 7 days \\[10\\]. It achieved an eradication rate of 97.4% by intention-to-treat (ITT) analysis and 99.1% by per-protocol (PP) analysis in a Taiwan population with clarithromycin resistance rate of 7%. Subsequent randomized controlled trials demonstrated that 14-day hybrid therapies were comparable or more effective than 10-day sequential therapies. A recent large multicentre randomized controlled trial documented that 14-day hybrid and 14-day concomitant therapies had comparable efficacy in the treatment of H. pylori infection, and both could cure more than 90% of patients with H. pylori infections in areas of high clarithromycin and metronidazole resistance \\[24\\]. Therefore, hybrid therapy has a great potential to replace bismuth quadruple therapy in the first-line treatment of H. pylori infection. Currently, hybrid therapy is a recommended first-line treatment for H. pylori infection in the ACG guideline\n\n, Bangkok Consensus Report and Taiwan Consensus Report. High-dose dual therapy developed by Yang et al. is another emerging treatment for H pylori infection. The new therapy consists of high-dose PPI and amoxicillin, which keep the intragastric pH at a value higher than 6.5 regardless of CYP2C19 genotype and maintain steady plasma concentration of amoxicillin above the minimal inhibitory concentration (MIC) for H pylori \\[28\\]. The efficacy of the new therapy was significantly higher than that of standard triple therapy in Taiwan. However, it was less effective as the first-line therapy for eradicating H pylori in Korea and in the United States.\n\nThis study aims to better understand the potential of both hybrid and igh-dose dual therapies in the treatment of H. pylori infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. H. pylori-infected outpatients with endoscopically proven peptic ulcer diseases or gastritis.\n\nExclusion Criteria:\n\n1. Previous H. pylori-eradication therapy\n2. ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks\n3. patients with allergic history to the medications used\n4. patients with previous gastric surgery\n5. the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)\n6. pregnant women.'}, 'identificationModule': {'nctId': 'NCT05152004', 'briefTitle': 'Efficacies of Hybrid and High-dose Dual Therapies for the First-line Anti-H Pylori Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Efficacies of Hybrid and High-dose Dual Therapies for the First-line Anti-H Pylori Treatment - a Randomized Trial', 'orgStudyIdInfo': {'id': '201800871A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose dual therapy', 'description': 'Rabeprazole (Pariet) 20 mg and amoxicillin (Amolin) 750 mg q.i.d for 14 days', 'interventionNames': ['Drug: Pariet', 'Drug: Amolin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hybrid therapy', 'description': 'Rabeprazole (Pariet) 20 mg and amoxicillin (Amolin) 1 g b.i.d. for 7 days, followed by rabeprazole (Pariet) 20 mg, amoxicillin(Amolin)1 g, clarithromycin (Klaricid) 500 mg, and metronidazole (Flagyl) 500 mg b.i.d. for 7 days', 'interventionNames': ['Drug: Pariet', 'Drug: Amolin', 'Drug: Klaricid', 'Drug: Flagyl']}], 'interventions': [{'name': 'Pariet', 'type': 'DRUG', 'otherNames': ['Rabeprazole'], 'description': 'Rabeprazole 20 mg and amoxicillin 750 mg qid for 14 days', 'armGroupLabels': ['High dose dual therapy', 'Hybrid therapy']}, {'name': 'Amolin', 'type': 'DRUG', 'otherNames': ['Amoxicillin'], 'description': 'Rabeprazole 20 mg and amoxicillin 750 mg qid for 14 days', 'armGroupLabels': ['High dose dual therapy', 'Hybrid therapy']}, {'name': 'Klaricid', 'type': 'DRUG', 'otherNames': ['Clarithromycin'], 'description': 'Rabeprazole 20 mg and amoxicillin 1 g bid. for 7 days, followed by rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg bid. for 7 days', 'armGroupLabels': ['Hybrid therapy']}, {'name': 'Flagyl', 'type': 'DRUG', 'otherNames': ['Metronidazole'], 'description': 'Rabeprazole 20 mg and amoxicillin 1 g bid. for 7 days, followed by rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg bid. for 7 days', 'armGroupLabels': ['Hybrid therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83300', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Wei-Chen Tai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Chang Gung Memorial Hospital,Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Wei-Chen Tai M.D.', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}