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

NCT07533266 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-04-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07533266 on ClinicalTrials.gov