Not Yet RecruitingPhase 4

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

South Korea360 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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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

What they're measuring

Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator

Timeframe: From enrollment to the end of treatment at 24 weeks

Trial details

NCT IDNCT07533266

SponsorDaewoong Pharmaceutical Co. LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Dr. Lee, MD, PhD

821025858941 2210498@daewoong.co.kr

View on ClinicalTrials.gov More NSAID (Non-Steroidal Anti-Inflammatory Drug) trials