A Phase 4 interventional study of levofloxacin-based sequential therapy and levofloxacin-based triple therapy for 10 days in Eradication Rate for Helicobacter, sponsored by National Taiwan University Hospital. Status unknown at 10 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-02-02.
Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment
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
About 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. Eligible patients will be randomized to receive either (1) 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)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. Eradication will be confirmed with 13C-Urea Breath Test 6 weeks after therapy.
National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
levofloxacin-based sequential therapy
Drug: levofloxacin-based sequential therapy
levofloxacin-based triple therapy for 10 days
Drug: 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)〕
Also known as: Takepron, Cravit, Flagyl, Amoxicillin
lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)
Also known as: Takepron, Cravit, Amoxicillin
Eradication rate in the second line therapy
Assessed by UBT
Time frame: 6 weeks
Incidence of adverse effect
during treatment
Time frame: 2 weeks
This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital