Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori

Phase 3 Completed 650 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to confirm the efficacy of triple therapy with TAK-438, Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive patients with scarred gastric or duodenal ulcers.

Timeline

Start: 2012-01
Primary completion: 2013-06
Completion: 2013-06

Outcome

Met primary endpoint

paper The first-line eradication rate (primary end point) was 92.6% (95% CI 89.2% to 95.2%) with vonoprazan versus 75.9% (95% CI PMID 26935876 ↗

paper with the difference being 16.7% (95% CI 11.2% to 22.1%) in favour of vonoprazan, thus confirming the non-inferiority of vonoprazan (p<0.0001). PMID 26935876 ↗

release “the non-inferiority of the first line therapy with TAK-438 to that with LPZ was verified” takeda.com ↗

release “Eradication rate: with TAK-438: 92.6% [300/324], with LPZ: 75.9% [243/320], p < 0.0001” takeda.com ↗

Publications

Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lansoprazole	Other / unclassified	30 mg	Oral
Subject	Vonoprazan	Other / unclassified	20 mg	Oral
Background	Amoxicillin	Other / unclassified	750 mg	Oral
Background	Clarithromycin	Small molecule	200 mg	Oral
Background	Clarithromycin	Small molecule	400 mg	Oral