Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs

Summary

This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.

Timeline

Start

2021-05-07

Primary completion

2025-07-01

Completion

2025-07-01

Outcome

Met primary endpoint

paper Tegoprazan was non-inferior to lansoprazole for the prevention of gastroduodenal ulcers (p=0.0004). PMID 42325011 ↗

Publications

• Kim SG, Kim TO, Jung SW, Min BH, Oh JH, Kim HS, Lee GH, Song JH, Sung IK, Cho YS, Choi SC, Lim YJ, Kim BW, Shin CM, Huh CW, Kim JW, Kim KO, Cho YK, Lee OY, Moon JS, Lee HW, Jung HY, Shin WG, Kim JG, Lee JY, Han SJ, Kim SW, Cho JH, Lim H, Kim TH, Park MI, Baik GH, Cha RR, Lee SK, Kim JJ. A Phase III, Randomized, Double-Blind, Active-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Tegoprazan for the Prevention of Peptic Ulcer in Patients on Continuous Long-Term Treatment with Nonsteroidal Anti-Inflammatory Drugs. Gut Liver. 2026 Jul 15;20(4):551-561. doi: 10.5009/gnl260057. Epub 2026 Jun 22.

Drugs

Indications