drugset

drugset / Trial / NCT01452711

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer

NCT01452711 ↗

Phase 3 Completed 482 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with gastric ulcer.

Timeline

Start: 2011-11
Primary completion: 2012-12
Completion: 2012-12

Publications

Miwa H, Uedo N, Watari J, Mori Y, Sakurai Y, Takanami Y, Nishimura A, Tatsumi T, Sakaki N. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials. Aliment Pharmacol Ther. 2017 Jan;45(2):240-252. doi: 10.1111/apt.13876. Epub 2016 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lansoprazole	Other / unclassified	30 mg	Oral
Subject	Vonoprazan	Other / unclassified	20 mg	Oral

Indications