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Not yet recruitingNCT07533266Updated Apr 16, 2026

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

A Phase 4 interventional study of Fexuprazan 20mg and Lansoprazole 15 mg placebo in NSAID (Non-Steroidal Anti-Inflammatory Drug), sponsored by Daewoong Pharmaceutical Co. LTD.. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • NSAID (Non-Steroidal Anti-Inflammatory Drug)
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    Fexuprazan 20mg

    Fexuprazan 20mg orally, once daily

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

  • Active comparator
    Lansoprazole 15mg

    Lansoprazole 15mg orally, once daily

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

Interventions

  • DrugFexuprazan 20mg

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

    Also known as: Fexuclue

  • 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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07533266
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Apr 16, 2026
Start date
Apr 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 16, 2026

Study contacts

Dr. Lee, MD, PhD
Contact
2210498@daewoong.co.kr
821025858941

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Daewoong Pharmaceutical Co. LTD.

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