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

NCT04198363 ↗

Phase 3 Completed 510 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

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

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

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

Timeline

Publications

Drugs

Indications