Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-01-16 @ 12:35 AM
Study NCT ID:
NCT02596620
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2015-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'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': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'luketai1019@gmail.com', 'phone': '886-975056026', 'title': 'Dr. Wei-Chen Tai', 'organization': 'Chang Gung Memorial Hospital, Taiwan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Sequential Therapy', 'description': 'Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days\n\nNexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms\n\nAmolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm\n\nCravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm\n\nFlagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm', 'otherNumAtRisk': 81, 'otherNumAffected': 19, 'seriousNumAtRisk': 81, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Triple Therapy', 'description': 'Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days\n\nNexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms\n\nAmolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm\n\nCravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm', 'otherNumAtRisk': 81, 'otherNumAffected': 9, 'seriousNumAtRisk': 81, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Successful Eradication of H. Pylori', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequential Therapy', 'description': 'Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days\n\nNexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms\n\nAmolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm\n\nCravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm\n\nFlagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm'}, {'id': 'OG001', 'title': 'Triple Therapy', 'description': 'Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days\n\nNexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms\n\nAmolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm\n\nCravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm'}], 'classes': [{'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '97.6'}, {'value': '81.5', 'groupId': 'OG001', 'lowerLimit': '72.8', 'upperLimit': '90.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Negative results of H.pylori 4 weeks after eradication', 'description': 'Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks.', 'unitOfMeasure': 'percentage of eradication', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequential Therapy', 'description': 'esomeprazole 40 mg bid and amoxicillin 1 g bid for 5 days, followed by esomeprazole 40 mg bid, levofloxacin 500 mg qd, and metronidazole 500 mg tid, for 5 days'}, {'id': 'FG001', 'title': 'Triple Therapy', 'description': 'levofloxacin 500 mg qd, amoxicillin 1 g bid, and esomeprazole 40 mg bid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Started from 1st October 2013', 'groupId': 'FG000', 'numSubjects': '82'}, {'comment': 'Started from 1st October 2013', 'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed on 30th September 2015', 'groupId': 'FG000', 'numSubjects': '81'}, {'comment': 'Completed on 30th September 2015', 'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '164 patients who had failed the H pylori eradication attempts using the standard triple therapy (proton pump inhibitor bid, clarithromycin 500 mg bid, amoxicillin 1 g bid × 7 days) were randomly assigned to either an sequential therapy group (EALM)(n = 82) or a 10-day levofloxacin-containing teriple therapy group (EAL)(n = 82).', 'preAssignmentDetails': 'We excluded those patients who had taken antibiotics, bismuth, proton-pump inhibitors, or non-steroidal anti-inflammatory drugs within the previous 4 weeks, were allergic to the medications used, had a history of previous gastric surgery or serious concomitant illness, or were currently pregnant.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequential Therapy', 'description': 'Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days\n\nNexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms\n\nAmolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm\n\nCravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm\n\nFlagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm'}, {'id': 'BG001', 'title': 'Triple Therapy', 'description': 'Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days\n\nNexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms\n\nAmolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm\n\nCravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-15', 'studyFirstSubmitDate': '2015-11-02', 'resultsFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2015-11-03', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-18', 'studyFirstPostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Successful Eradication of H. Pylori', 'timeFrame': 'Negative results of H.pylori 4 weeks after eradication', 'description': 'Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Proton pump inhibitor', 'Eradication'], 'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '22046084', 'type': 'RESULT', 'citation': 'Chuah SK, Tsay FW, Hsu PI, Wu DC. A new look at anti-Helicobacter pylori therapy. World J Gastroenterol. 2011 Sep 21;17(35):3971-5. doi: 10.3748/wjg.v17.i35.3971.'}, {'pmid': '12039901', 'type': 'RESULT', 'citation': 'Tanaka M, Isogai E, Isogai H, Hayashi S, Hirose K, Kimura K, Sugiyama T, Sato K. Synergic effect of quinolone antibacterial agents and proton pump inhibitors on Helicobacter pylori. J Antimicrob Chemother. 2002 Jun;49(6):1039-40. doi: 10.1093/jac/dkf055. No abstract available.'}, {'pmid': '25243116', 'type': 'RESULT', 'citation': 'Chuah SK, Tai WC, Lee CH, Liang CM, Hu TH. Quinolone-containing therapies in the eradication of Helicobacter pylori. Biomed Res Int. 2014;2014:151543. doi: 10.1155/2014/151543. Epub 2014 Aug 28.'}, {'pmid': '17854602', 'type': 'RESULT', 'citation': 'Vakil N, Megraud F. Eradication therapy for Helicobacter pylori. Gastroenterology. 2007 Sep;133(3):985-1001. doi: 10.1053/j.gastro.2007.07.008.'}, {'pmid': '19788600', 'type': 'RESULT', 'citation': 'Fock KM, Katelaris P, Sugano K, Ang TL, Hunt R, Talley NJ, Lam SK, Xiao SD, Tan HJ, Wu CY, Jung HC, Hoang BH, Kachintorn U, Goh KL, Chiba T, Rani AA; Second Asia-Pacific Conference. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol. 2009 Oct;24(10):1587-600. doi: 10.1111/j.1440-1746.2009.05982.x.'}, {'pmid': '20525969', 'type': 'RESULT', 'citation': 'Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.'}, {'pmid': '18446147', 'type': 'RESULT', 'citation': 'Graham DY, Shiotani A. New concepts of resistance in the treatment of Helicobacter pylori infections. Nat Clin Pract Gastroenterol Hepatol. 2008 Jun;5(6):321-31. doi: 10.1038/ncpgasthep1138. Epub 2008 Apr 29.'}, {'pmid': '26457027', 'type': 'RESULT', 'citation': 'Wu IT, Chuah SK, Lee CH, Liang CM, Lu LS, Kuo YH, Yen YH, Hu ML, Chou YP, Yang SC, Kuo CM, Kuo CH, Chien CC, Chiang YS, Chiou SS, Hu TH, Tai WC. Five-year sequential changes in secondary antibiotic resistance of Helicobacter pylori in Taiwan. World J Gastroenterol. 2015 Oct 7;21(37):10669-74. doi: 10.3748/wjg.v21.i37.10669.'}, {'pmid': '27175657', 'type': 'DERIVED', 'citation': 'Chuah SK, Liang CM, Lee CH, Chiou SS, Chiu YC, Hu ML, Wu KL, Lu LS, Chou YP, Chang KC, Kuo CH, Kuo CM, Hu TH, Tai WC. A Randomized Control Trial Comparing 2 Levofloxacin-Containing Second-Line Therapies for Helicobacter pylori Eradication. Medicine (Baltimore). 2016 May;95(19):e3586. doi: 10.1097/MD.0000000000003586.'}]}, 'descriptionModule': {'briefSummary': 'Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth salts are not available. The investigators compare the efficacies of 10-day levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients after failure of standard triple therapy and to determine what clinical and bacterial factors influencing the efficacy of salvage regimens.', 'detailedDescription': 'In this randomized-controlled trial , the investigator recruited participants with H pylori infection after failure of first line standard triple therapy. Using a computer-generated randomization sequence, the investigators randomly allocated patients to either 10-day levofloxacin-containing sequential (EALM, esomeprazole 40 mg b.d., amoxicillin 1 g b.d.for 5 days and followed by esomeprazole 40 mg b.d., levofloxacin 500 mg qd and metronidazole for 5 days) or 10-day levofloxacin-containing triple therapy (EAL, esomeprazole 40 mg b.d., amoxicillin 1 g b.d., and levofloxacin 500 mg qd) at a 1:1 ratio. The primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive H. pylori-infected participants, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis who failed first-line eradication therapies with standard triple regimens (PPI twice daily, 500 mg of clarithromycin twice daily and 1 g of amoxicillin twice daily)\n\nExclusion Criteria:\n\n* Ingestion of antibiotics, bismuth, or proton-pump inhibitors within the prior 4 weeks\n* Use of non-steroidal anti-inflammatory drugs within the prior 4 weeks\n* Participants with allergic history to the medications used\n* Participants with previous gastric surgery\n* The coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT02596620', 'briefTitle': 'Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Efficacy of 10-day Metronidazole and Levofloxacin Containing Sequential Therapy and 10-day Levofloxacin-containing Triple Therapy In Second Line Helicobacter Pylori Eradication Therapies', 'orgStudyIdInfo': {'id': 'CMRPG8C0201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequential therapy', 'description': 'Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days', 'interventionNames': ['Drug: Nexium', 'Drug: Amolin', 'Drug: Cravit', 'Drug: Flagyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triple therapy', 'description': 'Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days', 'interventionNames': ['Drug: Nexium', 'Drug: Amolin', 'Drug: Cravit']}], 'interventions': [{'name': 'Nexium', 'type': 'DRUG', 'otherNames': ['Esomeprazole'], 'description': 'Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms', 'armGroupLabels': ['Sequential therapy', 'Triple therapy']}, {'name': 'Amolin', 'type': 'DRUG', 'otherNames': ['Amoxicillin'], 'description': 'Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm', 'armGroupLabels': ['Sequential therapy', 'Triple therapy']}, {'name': 'Cravit', 'type': 'DRUG', 'otherNames': ['Levofloxacin'], 'description': 'Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm', 'armGroupLabels': ['Sequential therapy', 'Triple therapy']}, {'name': 'Flagyl', 'type': 'DRUG', 'otherNames': ['Metronidazole'], 'description': 'Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm', 'armGroupLabels': ['Sequential therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wei-Chen Tai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'mmmm'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Wei-Chen Tai M.D.', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}