Efficacy and Safety of LXI-15028 Comparing With Lansoprazole in the Treatment of Duodenal Ulcer

Phase 3 Completed 400 enrolled Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multi-center, randomized, double-blind, double-dummy, parallel-group, active-controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50mg comparing with Lansoprazole 30 mg after the treatment of duodenal ulcer in Chinese patients for up to 6 weeks.

Timeline

Start: 2021-10-18
Primary completion: 2022-09-28
Completion: 2022-09-28

Outcome

Met primary endpoint

paper CONCLUSIONS: Tegoprazan 50 mg once daily is effective and non-inferior to lansoprazole 30 mg once daily in Chinese patients with DU PMID 39378042 ↗

Publications

Zong Y, Lan C, Li X, Chen W, Chen H, Liao A, Liu S, Hu C, Wu Y, Zhang S. Efficacy and safety of tegoprazan for duodenal ulcers in Chinese patients: a multicenter, randomized, double-blind, non-inferiority, phase III study. Curr Med Res Opin. 2024 Nov;40(11):1855-1862. doi: 10.1080/03007995.2024.2414090. Epub 2024 Oct 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lansoprazole	Other / unclassified	30 mg	Oral
Subject	Tegoprazan	Other / unclassified	50 mg	Oral