NCT07533266

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSAID (Non-Steroidal Anti-Inflammatory Drug)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: South Korea