NSAID (Non-Steroidal Anti-Inflammatory Drug)Phase 4NCT07533266
Study to Evaluate the Efficacy and Safety of Fexuprazan in Prevention of NSAIDs Induced Peptic Ulcer
A Phase 4 study testing Fexuprazan 20mg and Lansoprazole 15 mg in people with NSAID (Non-Steroidal Anti-Inflammatory Drug), run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- NSAID (Non-Steroidal Anti-Inflammatory Drug)
- What is being tested?
- Fexuprazan 20mg and Lansoprazole 15 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Asan Medical Center
Seoul
Dr. Lee, 821025858941, 2210498@daewoong.co.kr
About this study
Official title: 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
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.
- Being tested
- Fexuprazan 20mg, Lansoprazole 15 mg placebo, Lansoprazole 15 mg, Fexuprazan 20mg placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexuprazan 20mgDrug
Also called Fexuclue
Fexuprazan 20mg, tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mg placeboDrug
Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks
Lansoprazole 15 mgDrug
Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks
Fexuprazan 20mg placeboDrug
Fexuprazan 20mg placebo-matching tablet, orally, once daily for up to 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fexuprazan 20mg | Experimental | Fexuprazan 20mg orally, once daily Receives: Drug: Fexuprazan 20mg; Drug: Lansoprazole 15 mg placebo |
| Lansoprazole 15mg | Active comparator | Lansoprazole 15mg orally, once daily Receives: Drug: Lansoprazole 15 mg; Drug: Fexuprazan 20mg placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSAID (Non-Steroidal Anti-Inflammatory Drug)Studies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533266
- Sponsor's protocol ID
- DW_DWP14012401
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07533266
- Acronym / sponsor ID
- DW_DWP14012401
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fexuprazan 20mg | Experimental | Drug: Fexuprazan 20mg, Drug: Lansoprazole 15 mg placeboFexuprazan 20mg orally, once daily |
| Lansoprazole 15mg | Active comparator | Drug: Lansoprazole 15 mg, Drug: Fexuprazan 20mg placeboLansoprazole 15mg orally, once daily |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fexuprazan 20mgAlso: FexuclueFexuprazan 20mg, tablet, orally, once daily for up to 24 weeks | Drug | Fexuprazan 20mg |
| Lansoprazole 15 mg placeboLansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks | Drug | Fexuprazan 20mg |
| Lansoprazole 15 mgLansoprazole 15mg capsule, orally, once daily for up to 24 weeks | Drug | Lansoprazole 15mg |
| Fexuprazan 20mg placeboFexuprazan 20mg placebo-matching tablet, orally, once daily for up to 24 weeks | Drug | Lansoprazole 15mg |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fexuprazan 20mg and Lansoprazole 15 mg in people with NSAID (Non-Steroidal Anti-Inflammatory Drug), run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Lee, MD, PhD (821025858941, 2210498@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.