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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
360
Fexuprazan 20mg, tablet, orally, once daily for up to 24 weeks
Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks
Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks
Asan Medical Center
Seoul, South Korea
Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator
Time frame: From enrollment to the end of treatment at 24 weeks
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Fexuprazan 20mg placebo-matching tablet, orally, once daily for up to 24 weeks