Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy
NCT ID: NCT01537055
Last Updated: 2015-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
600 participants
INTERVENTIONAL
2012-02-29
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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levofloxacin-based sequential therapy
levofloxacin-based sequential therapy
levofloxacin-based sequential therapy
levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕
levofloxacin-based triple therapy
levofloxacin-based triple therapy for 10 days
levofloxacin-based triple therapy for 10 days
lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)
Interventions
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levofloxacin-based sequential therapy
levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕
levofloxacin-based triple therapy for 10 days
lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* children and teenagers aged less than 20 years,
* history of gastrectomy,
* gastric malignancy, including adenocarcinoma and lymphoma,
* previous allergic reaction to antibiotics (amoxicillin, metronidazole, levofloxacin) and PPI (lansoprazole),
* contraindication to treatment drugs,
* pregnant or lactating women, or
* severe concurrent disease
20 Years
ALL
No
Sponsors
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E-DA Hospital
OTHER
National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University Hospital
National Taiwan University Hospital
Principal Investigators
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Jyh-Ming Liou, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital, Hsinchu Branch
Hsinchu, , Taiwan
E-DA Hospital and I-Shou University
Kaohsiung City, , Taiwan
Kaohsiung Medical University
Kaohsiung City, , Taiwan
Health Bureau of Lienchiang County
Lienchiang, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Veteran General Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taitung Branch, , Taiwan
National Taiwan University Hospital , Yunlin
Yunlin, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Wen-Fong Hsu
Role: primary
Chi-yang Chang
Role: primary
Jeng-Yih Wu
Role: primary
Feng-Yun Tsao
Role: primary
Wen-Hsiung Chang
Role: primary
Chun-Chao Chang
Role: primary
Jing-Chuan Luo
Role: primary
Ming-Jong Bair
Role: primary
Chieh-Chang Chen
Role: primary
References
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Liou JM, Chen CC, Chen MJ, Chang CY, Fang YJ, Lee JY, Sheng WH, Wang HP, Wu MS, Lin JT. Empirical modified sequential therapy containing levofloxacin and high-dose esomeprazole in second-line therapy for Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2011 Aug;66(8):1847-52. doi: 10.1093/jac/dkr217. Epub 2011 May 31.
Liou JM, Bair MJ, Chen CC, Lee YC, Chen MJ, Chen CC, Tseng CH, Fang YJ, Lee JY, Yang TH, Luo JC, Wu JY, Chang WH, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hung HW, Lin JT, Chang CY, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Levofloxacin Sequential Therapy vs Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori: A Randomized Trial. Am J Gastroenterol. 2016 Mar;111(3):381-7. doi: 10.1038/ajg.2015.439. Epub 2016 Feb 2.
Other Identifiers
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201110021MD
Identifier Type: -
Identifier Source: org_study_id
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