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NOT YET RECRUITING
NCT07533266
PHASE4

Study to Evaluate the Efficacy and Safety of Fexuprazan in Prevention of NSAIDs Induced Peptic Ulcer

Sponsor: Daewoong Pharmaceutical Co. LTD.

View on ClinicalTrials.gov

Summary

The study aims to demonstrate the preventive effect of Fexuprazan 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of Fexuprazan 20 mg.

Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Fexuclue Tab. in Prevention of NSAIDs-induced Peptic Ulcer

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2026-04

Completion Date

2027-12

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

DRUG

Fexuprazan 20mg

Fexuprazan 20mg, tablet, orally, once daily for up to 24 weeks

DRUG

Lansoprazole 15 mg placebo

Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks

DRUG

Lansoprazole 15 mg

Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks

DRUG

Fexuprazan 20mg placebo

Fexuprazan 20mg placebo-matching tablet, orally, once daily for up to 24 weeks

Locations (1)

Asan Medical Center

Seoul, South Korea