Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-10 @ 8:00 AM
Study NCT ID:
NCT03383003
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2017-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Novel First-line Anti-Helicobacter Pylori Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2017-12-17', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rates of H.pylori eradication', 'timeFrame': '6-8 weeks after treatment', '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': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori eradication', 'High dose proton pump inhibitor', 'High dose Amoxicillin', 'Concomitant therapy'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'The Asian-Pacific Consensus Report has recommended that proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. As a general rule for the treatment of other infectious diseases, clinicians should prescribe therapeutic regimens that have a per-protocol eradication rate ≥ 90% for anti-H pylori therapy. However, the eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently. The reasons for this fall in efficacy with time may relate to the increasing incidence of clarithromycin-resistant strains of H. pylori. Clarithromycin resistance is the major cause of eradication failure for stand triple therapy. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20% because the per-protocol eradication rates of standard therapies are often less than 85% and the intention-to-treat eradication rates are usually less than 80%..7-10 day non-bismuth containing quadruple therapy (Concomitant therapy) had been successful in the presence of clarithromycin resistance. Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy could also attained \\>90 eradication rate in some studies. This novel treatment is simple and involved only two drugs and the most important of all is that amoxicillin resistance is still 0% in Taiwan . High dose PPI has been used in several studies for H. pylori eradication in order to increase the intra-gastric PH for optimal eradication So far, there is still unclear which one is the best first-line H. pylori eradication regimen with highest eradication rate and least adverse effects. We therefore design a randomized controlled trial to simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the 7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and bacterial factors predicting the treatment outcomes of eradication therapies.', 'detailedDescription': 'The Asian-Pacific Consensus Report has recommended that proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. As a general rule for the treatment of other infectious diseases, clinicians should prescribe therapeutic regimens that have a per-protocol eradication rate ≥ 90% for anti-H pylori therapy. However, the eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently.\\[3-9\\] The reasons for this fall in efficacy with time may relate to the increasing incidence of clarithromycin-resistant strains of H. pylori. The main reasons for eradication failure for H pylori infection include antibiotic resistance, poor compliance and rapid metabolism of PPI. Clarithromycin resistance is the major cause of eradication failure for stand triple therapy. The rate of clarithromycin-resistant strains ranged from 49% (Spain) to 1% (Netherland) worldwide. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20% because the per-protocol eradication rates of standard therapies are often less than 85% and the intention-to-treat eradication rates are usually less than 80%. 7-10 day non-bismuth containing quadruple therapy (Concomitant therapy) had been successful in the presence of clarithromycin resistance. Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy could also attained \\>90 eradication rate in some studies. This novel treatment is simple and involved only two drugs and the most important of all is that amoxicillin resistance is still 0% in Taiwan. High dose PPI has been used in several studies for H. pylori eradication in order to increase the intra-gastric PH for optimal eradication So far, there is still unclear which one is the best first-line H. pylori eradication regimen with highest eradication rate and least adverse effects. We therefore design a randomized controlled trial to simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the 7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and bacterial factors predicting the treatment outcomes of eradication therapies.'}, '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': 'NCT03383003', 'briefTitle': 'Comparison of Two Novel First-line Anti-Helicobacter Pylori Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Comparison of Two Novel First-line Anti-Helicobacter Pylori Therapy: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'CMRMG8E1281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose dual therapy', 'description': 'Esomeprezole (Nexium)40 mg tid. and amoxicillin (Amolin) 750 mg qid. for 14 days', 'interventionNames': ['Drug: Nexium', 'Drug: Amolin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-bismuth quadruple therapy', 'description': 'Esomeprezole (Nexium) 40 mg bid.,clarithromycin (Klaricid) 500 mg bid., amoxicillin (Amolin) 1 g bid. and metronidazole (Flagyl) 500 mg bid. for 7 days', 'interventionNames': ['Drug: Nexium', 'Drug: Amolin', 'Drug: Klaricid', 'Drug: Flagyl']}], 'interventions': [{'name': 'Nexium', 'type': 'DRUG', 'otherNames': ['Esomeprazole'], 'description': 'Esomeprazole ( Nexium )40 mg tid daily for 14 days in the high dose dual therapyarm and 40 mg bid daily for 7 days in the non-bismuth quadruple therapy', 'armGroupLabels': ['High dose dual therapy', 'Non-bismuth quadruple therapy']}, {'name': 'Amolin', 'type': 'DRUG', 'otherNames': ['Amoxicillin'], 'description': 'Amoxicillin 750 mg qid daily for 14 days in the high dose dual therapy and amoxicillin 1 g bid daily for 7 days in the non-bismuth quadruple therapy', 'armGroupLabels': ['High dose dual therapy', 'Non-bismuth quadruple therapy']}, {'name': 'Klaricid', 'type': 'DRUG', 'otherNames': ['Clarithromycin'], 'description': 'clarithromycin 500 mg bid daily for 7 days in the non-bismuth quadruple therapy', 'armGroupLabels': ['Non-bismuth quadruple therapy']}, {'name': 'Flagyl', 'type': 'DRUG', 'otherNames': ['Metronidazole'], 'description': 'Metronidazole (Flagyl) 500 mg tid daily for 7 days in the non-bismuth quadruple therapy', 'armGroupLabels': ['Non-bismuth quadruple therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Wei-Chen Tai', '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'}}}}