drugset / Trial / NCT06168084

Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

NCT06168084

Phase 4 Completed 688 enrolled Yongquan Shi
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims at evaluating efficacy and safety of Vonorazon and amoxicillin dual therapy versus bismuth-containing quadruple Therapy(bismuth#esomeprazole#tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that Vonorazon 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
2023-06-06
Primary completion
2024-05-30
Completion
2024-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1000 mg Oral
Comparator Bismuth Potassium Citrate Unknown 220 mg Oral
Comparator Esomeprazole Small molecule 40 mg
Comparator Furazolidone Small molecule 100 mg
Comparator Tetracycline Unknown 500 mg
Subject Vonoprazan Other / unclassified 20 mg

Indications