Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection

Phase 3 Completed 533 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer.

Timeline

Start: 2017-04-05
Primary completion: 2019-03-19
Completion: 2019-07-19

Publications

Hou X, Wang J, Du Q, Tian D, Hu N, Liu D, Zhou F, Xie L, Gu L, Kudou K, Zhang S. Efficacy and Safety of Vonoprazan-Based Quadruple Therapy for the Eradication of Helicobacter pylori in Patients with Peptic Ulcers: A Pooled Analysis of Two Randomized, Double-Blind, Double-Dummy, Phase 3 Trials. Biol Pharm Bull. 2024;47(8):1405-1414. doi: 10.1248/bpb.b24-00011.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lansoprazole	Other / unclassified	30 mg	Oral
Subject	Vonoprazan	Other / unclassified	20 mg	Oral
Background	Amoxicillin	Other / unclassified	1 g	—
Background	Bismuth Potassium Citrate	Unknown	600 mg	—
Background	Clarithromycin	Small molecule	500 mg	—

Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection

Summary

Timeline

Publications

Drugs

Indications