clinical trial · NCT04840550
Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs
HK inno.N Corporation·phase3·completed·n = 392
Preventive Peptic UlcerLansoprazole 15 mgTegoprazan 25 mg
brief 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.
started
May 7, 2021
primary completion
Jul 1, 2025
completion
Jul 1, 2025
last updated
Sep 14, 2026
detailed description
This is a double-blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25 mg, lansoprazole 15 mg).
official title
A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol