Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease

Phase 4 Completed 218 enrolled HK inno.N Corporation

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to evaluate the efficacy and safety of Tegoprazan 50mg, compared to Lansoprazole 30mg in patients with healed erosive reflux disease confirmed by endoscopy following oral administration once daily(QD) of 2 weeks or 4 weeks.

Timeline

Start: 2021-02-16
Primary completion: 2022-05-25
Completion: 2022-05-25

Outcome

Met primary endpoint

paper The cumulative healing rates up to week 4 were 95.2% (98/103) and 86.2% (94/109) (difference [95% confidence interval], 8.91 [1.22-16.59]; PMID 39587796 ↗

paper p < 0.0001 for non-inferiority and 0.0266 for superiority PMID 39587796 ↗

paper Tegoprazan was superior to lansoprazole in the treatment of EE up to 4 weeks. PMID 39587796 ↗

Publications

Shin CM, Choi SC, Cho JW, Kim SY, Lee OJ, Kim DH, Cho YK, Lee JY, Lee SK, Shin JE, Kim GH, Park SY, Hong SJ, Jung HK, Lee SJ, Youn YH, Jeon SW, Sung IK, Park MI, Lee OY. Comparison of Tegoprazan and Lansoprazole in Patients With Erosive Esophagitis up to 4 Weeks: A Multi-Center, Randomized, Double-Blind, Active-Comparator Phase 4 Trial. Neurogastroenterol Motil. 2025 Jan;37(1):e14969. doi: 10.1111/nmo.14969. Epub 2024 Nov 25.

Drugs

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