NCT01537055|UnknownPhase 4DMC
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Sponsor study identifier
interventional
600
1 country
10
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 16, 2012
Actual (reported)February 22, 2012
Actual (reported)December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Eradication rate in the second line therapy
Assessed by UBT
6 weeks
Incidence of adverse effect
2 weeks
levofloxacin-based sequential therapy
levofloxacin-based triple therapy for 10 days
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)〕
National Taiwan University Hospital, Hsinchu Branch
Hsinchu, Taiwan
E-DA Hospital and I-Shou University
Kaohsiung City, Taiwan
Kaohsiung Medical University
Kaohsiung City, Taiwan
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.
Jyh-Ming Liou, MD
National Taiwan University Hospital
First Submitted
February 16, 2012
First Posted
February 22, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)
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Health Bureau of Lienchiang County
Lienchiang, Taiwan
National Taiwan University Hospital
Taipei, 10002, 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
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 2, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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