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Not yet recruiting NCT07533266

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

Phase IV Interventional NSAID (Non-Steroidal Anti-Inflammatory Drug)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fexuprazan 20mg, Lansoprazole 15 mg placebo, Lansoprazole 15 mg, Fexuprazan 20mg placebo.
Who it may be relevant to
Registry conditions: NSAID (Non-Steroidal Anti-Inflammatory Drug). Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

  • Male and female adults aged ≥ 19 years at the time of informed consent
  • Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
  • Subjects with at least one of the following risk factors for ulcer development at screening.
  • Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.

Exclusion criteria

  • Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
  • Subjects who have undergone gastroduodenal surgery or total small bowel resection
  • Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
  • Subjects who have had a malignant tumor in the last 5 years
  • Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Asan Medical Center — Seoul

Identifiers

NCT: NCT07533266 · DW_DWP14012401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗