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Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs
Sponsor: HK inno.N Corporation
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.
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
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
392
Start Date
2021-05-07
Completion Date
2025-07-01
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Lansoprazole 15 mg
Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
Tegoprazan 25 mg
Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
Locations (2)
Samsung Medical Center
Seoul, South Korea
The catholic univ. of Korea Eunpyeong ST. Mari's hospital
Seoul, South Korea