NCT01725906|UnknownPhase 4
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Sponsor study identifier
interventional
450
1 country
2
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
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.
October 31, 2012
Actual (reported)November 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 14, 2012
Actual (reported)May 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Eradication rate after third line rescue therapy
Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses. (genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status
8 weeks
eradication rates in subgroup analysis by antibiotic resistance and regimen
8 weeks
selection of antibiotic according to medication history
selection of antibiotics according to genotypic resistance
1. Nexium (esomeprazole), 40mg, bid, 14 days, plus 2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus 3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 4. Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
National Taiwan Universtiy Hospital
Taipei, Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Yun-Lin County, Taiwan
Liou JM, Chen PY, Luo JC, Lee JY, Chen CC, Fang YJ, Yang TH, Chang CY, Bair MJ, Chen MJ, Hsu YC, Hsu WF, Chang CC, Lin JT, Shun CT, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Efficacies of Genotypic Resistance-Guided vs Empirical Therapy for Refractory Helicobacter pylori Infection. Gastroenterology. 2018 Oct;155(4):1109-1119. doi: 10.1053/j.gastro.2018.06.047. Epub 2018 Jun 30.
Jyh-Ming Liou
National Taiwan University Hospital
First Submitted
October 31, 2012
First Posted
November 14, 2012
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2017
Estimated (date passed)WheelSee Feasibility Study
1. Nexium (esomeprazole), 40mg, bid, 14 days, plus 2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus 3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 4. Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 8, 2017
Record last verified: 2017-05
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