drugset / Trial / NCT02835560

Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection

NCT02835560

RandomizedParallel-groupOpen-labelTreatment

Summary

This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori. Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 14 days, participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID. After treatment, the healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.

Timeline

Start
2013-06
Primary completion
2015-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esoprazole Unknown 20 mg
Subject Ilaprazole Small molecule 5 mg
Comparator Amoxicillin Other / unclassified 1000 mg
Comparator Bismuth Potassium Citrate Unknown 220 mg
Comparator Clarithromycin Small molecule 500 mg

Indications

No indication recorded.