Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer

Summary

The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.

Timeline

Start

2021-05-21

Primary completion

2023-11-27

Completion

2023-12-11

Outcome

Met primary endpoint

paper with a between-group difference of -1.64% (95% confidence interval, -4.52% to 1.25%), demonstrating non-inferiority. PMID 40567214 ↗

Publications

• Hong S, Ju JH, Lee SH, Hong SJ, Kim SH, Ahn GY, Jung JH, Hur JW, Ha YJ, Park JK, Kim HS, Lee SW, Park YB, Lim MJ, Kim YS, Song JS, Choi CB, Kim SH, Choi IA, Choi KD, Lee TH, Cho YS, Lee YC, Kwon KS, Lee H, Park M, Heo J, Baek S, Lee CK. Comparing the Efficacy and Safety of Fexuprazan and Lansoprazole for the Prevention of Nonsteroidal Anti-inflammatory Drug-Induced Peptic Ulcer. Gut Liver. 2025 Sep 15;19(5):685-695. doi: 10.5009/gnl250019. Epub 2025 Jun 26.

Drugs

Indications