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

NCT07533266 — Phase 4, Not yet recruiting, 360 participants, Daewoong Pharmaceutical Co. LTD.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07533266
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	360 (Estimated)
Sponsor	Daewoong Pharmaceutical Co. LTD. (Industry)
Conditions	NSAID (Non-Steroidal Anti-Inflammatory Drug)
Interventions	Fexuprazan 20mg, Lansoprazole 15 mg placebo, Lansoprazole 15 mg, Fexuprazan 20mg placebo (Drug)
Dates	start 2026-04-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-04-16, last updated 2026-04-16
Locations	1 site in South Korea

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Fexuprazan 20mg	Experimental	Drug: Fexuprazan 20mg; Drug: Lansoprazole 15 mg placebo	Fexuprazan 20mg orally, once daily
Lansoprazole 15mg	Active comparator	Drug: Lansoprazole 15 mg; Drug: Fexuprazan 20mg placebo	Lansoprazole 15mg orally, once daily

Fexuprazan 20mg (Drug), also known as Fexuclue: Fexuprazan 20mg, tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mg placebo (Drug): Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks
Lansoprazole 15 mg (Drug): Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks
Fexuprazan 20mg placebo (Drug): Fexuprazan 20mg placebo-matching tablet, orally, once daily for up to 24 weeks

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

Facility	City	Country	Status
Asan Medical Center	Seoul	South Korea