Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT01667718
Status:
COMPLETED
Last Update Posted:
2012-12-13
First Post:
2012-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001729', 'term': 'Bismuth'}, {'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'D054328', 'term': 'Proton Pump Inhibitors'}, {'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D004603', 'term': 'Elements, Radioactive'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D011868', 'term': 'Radioisotopes'}, {'id': 'D007554', 'term': 'Isotopes'}, {'id': 'D008670', 'term': 'Metals'}, {'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': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-12', 'studyFirstSubmitDate': '2012-06-05', 'studyFirstSubmitQcDate': '2012-08-16', 'lastUpdatePostDateStruct': {'date': '2012-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eradication rate of Helicobacter pylori', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['eradication', 'helicobacter pylori', 'bismuth'], 'conditions': ['Functional Dyspepsia', 'Peptic Ulcer']}, 'descriptionModule': {'briefSummary': 'To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.', 'detailedDescription': 'The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer\n\nExclusion Criteria:\n\n* patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications'}, 'identificationModule': {'nctId': 'NCT01667718', 'briefTitle': 'Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Levofloxacin-containing Therapy for Helicobacter Pylori Treatment', 'orgStudyIdInfo': {'id': 'rjkls2012011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levofloxacin-triple therapy', 'description': 'Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin', 'interventionNames': ['Drug: Lansoprazole', 'Drug: Levofloxacin', 'Drug: Amoxicillin']}, {'type': 'EXPERIMENTAL', 'label': 'Levofloxacin-quadruple therapy', 'description': 'Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin', 'interventionNames': ['Drug: Bismuth', 'Drug: Lansoprazole', 'Drug: Levofloxacin', 'Drug: Amoxicillin']}], 'interventions': [{'name': 'Bismuth', 'type': 'DRUG', 'otherNames': ['Bismuth potassium citrate'], 'description': 'Bismuth 220mg b.i.d for 2 weeks', 'armGroupLabels': ['Levofloxacin-quadruple therapy']}, {'name': 'Lansoprazole', 'type': 'DRUG', 'otherNames': ['Proton Pump Inhibitor'], 'description': 'Lansoprazole 30 mg b.i.d.for 2 weeks', 'armGroupLabels': ['Levofloxacin-quadruple therapy', 'Levofloxacin-triple therapy']}, {'name': 'Levofloxacin', 'type': 'DRUG', 'description': 'Levofloxacin 0.5 q.d. for 2 weeks', 'armGroupLabels': ['Levofloxacin-quadruple therapy', 'Levofloxacin-triple therapy']}, {'name': 'Amoxicillin', 'type': 'DRUG', 'description': 'Amoxicillin 1 g b.i.d. for 2 weeks', 'armGroupLabels': ['Levofloxacin-quadruple therapy', 'Levofloxacin-triple therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Jiao-Tong University School of Medicine Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Hong Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Jiao-Tong University School of Medicine Renji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of GI Division', 'investigatorFullName': 'Dr. HONG LU', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}