drugset / Trial / NCT04678492

Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

NCT04678492

Phase 4 Completed 658 enrolled Xijing Hospital of Digestive Diseases
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth,esomeprazole,tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test,rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Timeline

Start
2020-12-20
Primary completion
2021-12-20
Completion
2021-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1000 mg Oral
Comparator Bismuth Potassium Citrate Unknown 220 mg Oral
Comparator Esomeprazole Small molecule 40 mg Oral
Comparator Furazolidone Small molecule 100 mg Oral
Comparator Tetracycline Unknown 500 mg Oral