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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07533266

Enrollment

360

Registered

2026-04-16

Start date

2026-04-01

Completion date

2027-12-01

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSAID (Non-Steroidal Anti-Inflammatory Drug)

Brief 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.

Interventions

DRUGFexuprazan 20mg

Fexuprazan 20mg, tablet, orally, once daily for up to 24 weeks

DRUGLansoprazole 15 mg placebo

Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks

DRUGLansoprazole 15 mg

Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks

DRUGFexuprazan 20mg placebo

Fexuprazan 20mg placebo-matching tablet, orally, once daily for up to 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male and female adults aged ≥ 19 years at the time of informed consent 2. Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks 3. Subjects with at least one of the following risk factors for ulcer development at screening. 4. 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

1. Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results. 2. Subjects who have undergone gastroduodenal surgery or total small bowel resection 3. Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system 4. Subjects who have had a malignant tumor in the last 5 years 5. Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs

Design outcomes

Primary

Measure	Time frame
Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator	From enrollment to the end of treatment at 24 weeks

Countries

South Korea

Contacts

CONTACTDr. Lee, MD, PhD

2210498@daewoong.co.kr821025858941

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026