Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-06 @ 5:08 PM
Study NCT ID:
NCT04531059
Status:
COMPLETED
Last Update Posted:
2024-12-30
First Post:
2020-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rescue Therapy for Helicobacter Pylori Eradication Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562573', 'term': 'cyclopia sequence'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D013752', 'term': 'Tetracycline'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D008911', 'term': 'Minocycline'}], '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': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 368}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, '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': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'rescue therapy', 'minocycline', 'tetracycline'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability and willingness to participate in the study and to sign and give informed consent\n* Confirmed H. pylori infection and with previous treatment failure\n\nExclusion Criteria:\n\n* subjects naive to H. pylori treatment,\n* under 18 or over 80 years old\n* history of gastrectomy\n* pregnant or lactating women\n* severe systemic diseases or malignancy\n* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks\n* contraindications to the study drugs'}, 'identificationModule': {'nctId': 'NCT04531059', 'briefTitle': 'Rescue Therapy for Helicobacter Pylori Eradication Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Rescue Therapy for Helicobacter Pylori Eradication: a Randomized Non-Inferiority Trial of Minocycline or Tetracycline in Bismuth Quadruple Therapy', 'orgStudyIdInfo': {'id': 'rjkls2019013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tetracycline Bismuth Quadruple Therapy', 'description': 'Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid', 'interventionNames': ['Drug: Esomeprazole', 'Drug: Bismuth Potassium Citrate', 'Drug: Tetracycline,Metronidazole']}, {'type': 'EXPERIMENTAL', 'label': 'Minocycline Bismuth Quadruple Therapy', 'description': 'Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid', 'interventionNames': ['Drug: Esomeprazole', 'Drug: Bismuth Potassium Citrate', 'Drug: Minocycline,Metronidazole']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'description': 'Proton pump inhibitor', 'armGroupLabels': ['Minocycline Bismuth Quadruple Therapy', 'Tetracycline Bismuth Quadruple Therapy']}, {'name': 'Bismuth Potassium Citrate', 'type': 'DRUG', 'description': 'Gastric mucosal protective drug with anti-H. pylori effect', 'armGroupLabels': ['Minocycline Bismuth Quadruple Therapy', 'Tetracycline Bismuth Quadruple Therapy']}, {'name': 'Tetracycline,Metronidazole', 'type': 'DRUG', 'description': 'Antibiotics for H. pylori eradication', 'armGroupLabels': ['Tetracycline Bismuth Quadruple Therapy']}, {'name': 'Minocycline,Metronidazole', 'type': 'DRUG', 'description': 'Antibiotics for H. pylori eradication', 'armGroupLabels': ['Minocycline Bismuth Quadruple Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200120', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai East Hospital, Tongji University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University school of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine', 'investigatorFullName': 'Hong Lu, MD', 'investigatorAffiliation': 'RenJi Hospital'}}}}