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

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

Outcome

Met primary endpoint

paper VHA therapy remained non-inferior to TFEB in ITT, MITT, and PP analyses. PMID 40543051 ↗

paper The 14-day VHA dual therapy was non-inferior to bismuth-containing quadruple therapy PMID 40543051 ↗

Publications

Zhang J, Wang X, Song S, Zhu X, Lv T, Wang L, Lei L, Wang Y, Lei Y, Wang Y, Zhu X, Zhang L, Chen M, Shi Y. Efficacy and Safety of Vonoprazan and High-Dose Amoxicillin Dual Therapy for Rescue Treatment of Helicobacter pylori Infection: A Multicenter Randomized Controlled Trial. United European Gastroenterol J. 2025 Oct;13(8):1541-1549. doi: 10.1002/ueg2.70070. Epub 2025 Jun 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
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	—