A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

Summary

The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants.

Timeline

Start

2020-04-30

Primary completion

2021-11-01

Completion

2021-11-25

Outcome

Met primary endpoint

paper non-inferiority P = 0.0009 PMID 39965795 ↗

paper Vonoprazan was found to be well-tolerated and non-inferior to esomeprazole for eradicating H. pylori in patients from China. PMID 39965795 ↗

Publications

• Song Z, Du Q, Zhang G, Zhang Z, Liu F, Lu N, Gu L, Kuroda S, Zhou L. Vonoprazan-based quadruple therapy is non-inferior to esomeprazole-based quadruple therapy for Helicobacter pylori eradication: A multicenter, double-blind, randomized, phase 3 study. Chin Med J (Engl). 2025 Nov 20;138(22):2938-2946. doi: 10.1097/CM9.0000000000003437. Epub 2025 Feb 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Esomeprazole	Small molecule	20 mg	Oral
Subject	Vonoprazan	Other / unclassified	20 mg	Oral
Background	Amoxicillin	Other / unclassified	1 g	Oral
Background	Bismuth Potassium Citrate	Unknown	600 mg	Oral
Background	Clarithromycin	Small molecule	500 mg	Oral

Indications