Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-30 @ 11:36 PM
Study NCT ID:
NCT05342532
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Sponsor:
Organization:
Raw JSON
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Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 5, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Triple Therapy', 'description': 'This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.\n\nClarithromycin: 500 mg twice daily', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 20, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Dysguesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participant With Eradication of Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Dual Therapy', 'description': 'This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.'}, {'id': 'OG001', 'title': 'Standard Triple Therapy', 'description': 'This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.\n\nClarithromycin: 500 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'end of study at 6 weeks', 'description': 'The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Protocol Specific Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Dual Therapy', 'description': 'This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.'}, {'id': 'OG001', 'title': 'Standard Triple Therapy', 'description': 'This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.\n\nClarithromycin: 500 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'end of study at 6 weeks', 'description': 'Patient tolerability determined by adverse event rates noted by the presence of abdominal pain, diarrhea, dysgeusia, nausea, vomiting, dysphagia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Completing at Least 90% of All Prescribed Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Dual Therapy', 'description': 'This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.'}, {'id': 'OG001', 'title': 'Standard Triple Therapy', 'description': 'This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.\n\nClarithromycin: 500 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'end of study at 6 weeks', 'description': 'Patients were provided a medication log to self-report drug compliance. After completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. At the post-treatment visit, a medication log and empty pill bottles were brought in to ascertain compliance (defined as completing at least 90% of all prescribed medications).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Dose Dual Therapy', 'description': 'This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.'}, {'id': 'FG001', 'title': 'Standard Triple Therapy', 'description': 'This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.\n\nClarithromycin: 500 mg twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Dose Dual Therapy', 'description': 'This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.'}, {'id': 'BG001', 'title': 'Standard Triple Therapy', 'description': 'This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.\n\nAmoxicillin: 1 g\n\nOmeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.\n\nClarithromycin: 500 mg twice daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'spread': '15', 'groupId': 'BG000'}, {'value': '52.7', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '51', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '58', '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'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2019-01-02', 'size': 300693, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-27T14:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01-05', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2022-04-19', 'resultsFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-06', 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participant With Eradication of Disease', 'timeFrame': 'end of study at 6 weeks', 'description': 'The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Protocol Specific Adverse Events', 'timeFrame': 'end of study at 6 weeks', 'description': 'Patient tolerability determined by adverse event rates noted by the presence of abdominal pain, diarrhea, dysgeusia, nausea, vomiting, dysphagia'}, {'measure': 'Number of Participants Completing at Least 90% of All Prescribed Medications', 'timeFrame': 'end of study at 6 weeks', 'description': 'Patients were provided a medication log to self-report drug compliance. After completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. At the post-treatment visit, a medication log and empty pill bottles were brought in to ascertain compliance (defined as completing at least 90% of all prescribed medications).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-dose dual therapy', 'standard triple therapy', 'helicobacter pylori eradication', 'clarithromycin resistance'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'A phase 4 prospective, randomized, open-label clinical trial evaluating the efficacy of high dose dual therapy vs standard triple therapy in a diverse, urban New York City population.', 'detailedDescription': "All patients, at least 18 years of age, with a chief complaint of dyspepsia and documented treatment-naïve HP infection diagnosed on UBT, esophagogastroduodenoscopy (EGD) with HP biopsy, or SAT were recruited for the study. Dyspepsia was defined as persistent or recurrent abdominal pain for at least one month. All subjects who met inclusion criteria were randomly assigned by a computerized system to one of two treatment groups: standard triple therapy (STT) or high-dose dual therapy (HDDT). After patient randomization, all potential side effects were discussed. Education regarding the importance of adherence to complete the full 14 day regimen was provided. Patients were provided an electronic prescription for the respective assigned regimen along with a medication log to self-report drug compliance. The patients were asked to record medication compliance and report any adverse events to research personnel.\n\nAfter completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. During this period, patients were asked to abstain from taking PPI's to avoid false negative eradication testing. At the post-treatment visit, a medication log and empty pill bottles were brought in to ascertain compliance (defined as completing at least 90% of all prescribed medications)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Treatment-naïve\n* Clinical diagnosis of helicobacter pylori infection based on urea breath test, endoscopy or stool antigen test\n* Subject willing to participate and able to provide informed consent.\n\nExclusion Criteria:\n\n* Prior helicobacter pylori treatment failure\n* Antibiotic exposure within the past 4 weeks of helicobacter pylori diagnosis\n* Pregnancy or breastfeeding\n* Penicillin allergy\n* History of active or non-gastric malignancy\n* Severe illness requiring hospitalization during treatment period\n* Starting additional antibiotic while on treatment'}, 'identificationModule': {'nctId': 'NCT05342532', 'briefTitle': 'High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'High-Dose Dual Therapy vs Standard Triple Therapy for Treatment-Naïve H. Pylori: A Prospective Randomized Control Trial in a Diverse Urban New York City Population', 'orgStudyIdInfo': {'id': 'STUDY-19-01590'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Dose Dual Therapy', 'description': 'This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.', 'interventionNames': ['Drug: Amoxicillin', 'Drug: Omeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard triple therapy', 'description': 'This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.', 'interventionNames': ['Drug: Amoxicillin', 'Drug: Omeprazole', 'Drug: Clarithromycin']}], 'interventions': [{'name': 'Amoxicillin', 'type': 'DRUG', 'description': '1 g', 'armGroupLabels': ['High Dose Dual Therapy', 'Standard triple therapy']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': '40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.', 'armGroupLabels': ['High Dose Dual Therapy', 'Standard triple therapy']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'description': '500 mg twice daily', 'armGroupLabels': ['Standard triple therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Union Square Division of Digestive Diseases', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ilan Weisberg, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Beth Israel'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Ilan S Weisberg', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}