Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-02 @ 10:49 AM
Study NCT ID:
NCT02646332
Status:
COMPLETED
Last Update Posted:
2020-11-24
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D008795', 'term': 'Metronidazole'}], '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': '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'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'williamhsup@yahoo.com.tw', 'phone': '+886-7-3422121', 'title': 'Dr. Ping-I Hsu', 'phoneExt': '78233', 'organization': 'Kaohsiung Veterans General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The trial was performed in a single country'}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': '(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox)', 'description': 'a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily\n\n(dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 25, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexlan+Clarith+Amox+Metro', 'description': 'dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days\n\ndexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 48, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants in Which H. Pylori Was Eradicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox)', 'description': 'a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily\n\n(dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily'}, {'id': 'OG001', 'title': 'Dexlan+Clarith+Amox+Metro', 'description': 'dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days\n\ndexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'sixth week after the end of anti- H. pylori therapy', 'description': 'To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox)', 'description': 'a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily\n\n(dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily'}, {'id': 'FG001', 'title': 'Dexlan+Clarith+Amox+Metro', 'description': 'dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days\n\ndexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox)', 'description': 'a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily\n\n(dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily'}, {'id': 'BG001', 'title': 'Dexlan+Clarith+Amox+Metro', 'description': 'dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days\n\ndexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '55.5', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of smoking', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-31', 'size': 312375, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-29T02:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-01', 'studyFirstSubmitDate': '2016-01-04', 'resultsFirstSubmitDate': '2020-11-01', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-01', 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants in Which H. Pylori Was Eradicated', 'timeFrame': 'sixth week after the end of anti- H. pylori therapy', 'description': 'To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Eradication rate'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.', 'detailedDescription': 'A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis\n\nExclusion Criteria:\n\n* previous H pylori-eradication therapy\n* ingestion of antibiotics or bismuth within the prior 4 weeks\n* patients with allergic history to the medications used\n* patients with previous gastric surgery\n* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT02646332', 'briefTitle': 'Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Veterans General Hospital.'}, 'officialTitle': 'Comparing the Efficacy and Impact on Gastrointestinal Microbiota of Reverse Hybrid Therapy and Concomitant Therapy in Helicobacter Pylori Eradication', 'orgStudyIdInfo': {'id': 'VGHKS15-CT7-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(dexlan+amox+clar+metr)+(dexlan+amox)', 'description': 'a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily', 'interventionNames': ['Drug: (dexlan+amox+clar+metr)+(dexlan+amox)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexlan+clarith+amox+metro', 'description': 'dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days', 'interventionNames': ['Drug: dexlan+clarith+amox+metro']}], 'interventions': [{'name': '(dexlan+amox+clar+metr)+(dexlan+amox)', 'type': 'DRUG', 'otherNames': ['dexlansoprazole MR 60 mg', 'amoxicillin 1 g', 'clarithromycin 500 mg', 'metronidazole 250 mg'], 'description': 'a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily', 'armGroupLabels': ['(dexlan+amox+clar+metr)+(dexlan+amox)']}, {'name': 'dexlan+clarith+amox+metro', 'type': 'DRUG', 'otherNames': ['dexlansoprazole MR 60 mg', 'clarithromycin 500 mg', 'amoxicillin 1 g', 'metronidazole 250 mg'], 'description': 'dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days', 'armGroupLabels': ['dexlan+clarith+amox+metro']}]}, 'contactsLocationsModule': {'locations': [{'zip': '813', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Ping-I Hsu, Bachelor', 'role': 'STUDY_CHAIR', 'affiliation': 'Kaohsiung Veterans General Hospital.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Veterans General Hospital.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ping-I (William) Hsu, M.D.', 'investigatorAffiliation': 'Kaohsiung Veterans General Hospital.'}}}}