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COMPLETED
NCT04840550
PHASE3

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

Sponsor: HK inno.N Corporation

View on ClinicalTrials.gov

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

Interventions

DRUG

Lansoprazole 15 mg

Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.

DRUG

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