Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

Phase 4 Unknown 234 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University

RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to evaluate the efficacy of vonoprazan compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits.

Timeline

Start: 2021-05-18
Primary completion: 2022-04-13
Completion: 2022-04-13

Outcome

Met primary endpoint

paper Quadruple therapy with vonoprazan 20 mg daily was noninferior to the esomeprazole-based regimen (Farrington and Manning test: margin 10%, significance level 2.5%). PMID 36458325 ↗

Publications

Lu L, Wang Y, Ye J, Han Y, Lou G, Li Y, Yan H, Du Q. Quadruple therapy with vonoprazan 20 mg daily as a first-line treatment for Helicobacter pylori infection: A single-center, open-label, noninferiority, randomized controlled trial. Helicobacter. 2023 Feb;28(1):e12940. doi: 10.1111/hel.12940. Epub 2022 Dec 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Esomeprazole	Small molecule	20 mg	—
Subject	Vonoprazan	Other / unclassified	20 mg	—
Background	Amoxicillin	Other / unclassified	1 g	—
Background	Furazolidone	Small molecule	0.1 g	—
Background	colloidal bismuth pectin	Unknown	200 mg	—