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Study to Evaluate the Efficacy and Safety of Fexuprazan in Prevention of NSAIDs Induced Peptic Ulcer
Sponsor: Daewoong Pharmaceutical Co. LTD.
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
Fexuprazan 20mg
Fexuprazan 20mg, tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mg placebo
Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks
Lansoprazole 15 mg
Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks
Fexuprazan 20mg placebo
Fexuprazan 20mg placebo-matching tablet, orally, once daily for up to 24 weeks
Locations (1)
Asan Medical Center
Seoul, South Korea