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

NCT07533266 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: DW_DWP14012401
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

NSAID (Non-Steroidal Anti-Inflammatory Drug)

Outcome Measures

Primary Outcomes (1)

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

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Fexuprazan 20mg

EXPERIMENTAL

Fexuprazan 20mg orally, once daily

Drug: Fexuprazan 20mg; Drug: Lansoprazole 15 mg placebo

Lansoprazole 15mg

ACTIVE COMPARATOR

Lansoprazole 15mg orally, once daily

Drug: Lansoprazole 15 mg; Drug: Fexuprazan 20mg placebo

Interventions

Fexuprazan 20mg DRUG

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

Also known as: Fexuclue

Fexuprazan 20mg

Lansoprazole 15 mg placebo DRUG

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

Fexuprazan 20mg

Lansoprazole 15 mg DRUG

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

Lansoprazole 15mg

Fexuprazan 20mg placebo DRUG

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

Lansoprazole 15mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

fexuprazan; Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Dr. Lee, MD, PhD

CONTACT

821025858941; 2210498@daewoong.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)