Preventive Peptic UlcerPhase 3NCT04840550
Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs
A Phase 3 study testing Lansoprazole 15 mg and Tegoprazan 25 mg in people with Preventive Peptic Ulcer, run by HK inno.N Corporation at 2 sites in South Korea.
Trial summary
This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Preventive Peptic Ulcer
- What is being tested?
- Lansoprazole 15 mg and Tegoprazan 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 7 May 2021to 1 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥60 years of age, or ≥20 years of age with a history of gastroduodenal ulcers (gastric and/or duodenal ulcers) at screening
- Requires continued treatment with NSAIDs for ≥24 weeks
Who cannot join
- Has an active stage (A1, A2) or healing stage (H1, H2) of gastroduodenal ulcers per the Sakita-Miwa classification identified by upper GI endoscopy at screening
- Has uncontrolled severe hypertension
- Has severe heart failure, congestive heart failure (NYHA Ⅱ to Ⅳ), ischemic heart disease (unstable angina, myocardial infarction), or peripheral artery disease, or has undergone coronary artery bypass graft (CABG) who is considered ineligible for treatment with NSAIDs
- Has a positive H. pylori test at screening
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical Center
Seoul
The catholic univ. of Korea Eunpyeong ST. Mari's hospital
Seoul
About this study
Official title: A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs
This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.
Read the detailed description
This is a double-blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25 mg, lansoprazole 15 mg).
- Conditions
- Preventive Peptic Ulcer
- Being tested
- Lansoprazole 15 mg, Tegoprazan 25 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole 15 mgDrug
Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
Tegoprazan 25 mgDrug
Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 25mg | Experimental | Tegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months. Receives: Drug: Tegoprazan 25 mg |
| Lansoprazole 15mg | Active comparator | Lansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months. Receives: Drug: Lansoprazole 15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with gastric and/or duodenal ulcers at Week 24
The proportion of subjects with gastric and/or duodenal ulcers on upper GI endoscopy at Week 24
Measured: week 24
Secondary outcomes (1)
Proportion of subjects without NSAID-related GI symptoms at Weeks 4, 12, and 24
GI symptoms are as follows; Heartburn, Regurgitation, Upper abdominal pain or discomfort
Measured: week 4, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start7 May 2021
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preventive Peptic UlcerStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jea Jun Kim, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840550
- Sponsor's protocol ID
- IN_APA_308
- Status last verified
- Mar 2025
- First submitted
- 7 Apr 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SG, Kim TO, Jung SW, Min BH, Oh JH, Kim HS, Lee GH, Song JH, Sung IK, Cho YS, Choi SC, Lim YJ, Kim BW, Shin CM, Huh CW, Kim JW, Kim KO, Cho YK, Lee OY, Moon JS, Lee HW, Jung HY, Shin WG, Kim JG, Lee JY, Han SJ, Kim SW, Cho JH, Lim H, Kim TH, Park MI, Baik GH, Cha RR, Lee SK, Kim JJ. A Phase III, Randomized, Double-Blind, Active-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Tegoprazan for the Prevention of Peptic Ulcer in Patients on Continuous Long-Term Treatment with Nonsteroidal Anti-Inflammatory Drugs. Gut Liver. 2026 Jul 15;20(4):551-561. doi: 10.5009/gnl260057. Epub 2026 Jun 22.
PubMed 42325011
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs
- ClinicalTrials.gov ID
- NCT04840550
- Acronym / sponsor ID
- IN_APA_308
- Conditions
- Preventive Peptic Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 May 2021 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 12 Apr 2021 (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.
This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.
Detailed description
This is a double-blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25 mg, lansoprazole 15 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 |
|---|---|---|
| Tegoprazan 25mg | Experimental | Drug: Tegoprazan 25 mgTegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months. |
| Lansoprazole 15mg | Active comparator | Drug: Lansoprazole 15 mgLansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥60 years of age, or ≥20 years of age with a history of gastroduodenal ulcers (gastric and/or duodenal ulcers) at screening
- Requires continued treatment with NSAIDs for ≥24 weeks
Key exclusion criteria (4 listed)
- Has an active stage (A1, A2) or healing stage (H1, H2) of gastroduodenal ulcers per the Sakita-Miwa classification identified by upper GI endoscopy at screening
- Has uncontrolled severe hypertension
- Has severe heart failure, congestive heart failure (NYHA Ⅱ to Ⅳ), ischemic heart disease (unstable angina, myocardial infarction), or peripheral artery disease, or has undergone coronary artery bypass graft (CABG) who is considered ineligible for treatment with NSAIDs
- Has a positive H. pylori test at screening
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 |
|---|---|---|
| Lansoprazole 15 mgLansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months. | Drug | Lansoprazole 15mg |
| Tegoprazan 25 mgTegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months. | Drug | Tegoprazan 25mg |
Primary outcome
Proportion of subjects with gastric and/or duodenal ulcers at Week 24
Time frame: week 24
The proportion of subjects with gastric and/or duodenal ulcers on upper GI endoscopy at Week 24
1 secondary outcome
Proportion of subjects without NSAID-related GI symptoms at Weeks 4, 12, and 24
Time frame: week 4, 12, 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 42325011Kim SG, Kim TO, Jung SW, Min BH, Oh JH, Kim HS, Lee GH, Song JH, Sung IK, Cho YS, Choi SC, Lim YJ, Kim BW, Shin CM, Huh CW, Kim JW, Kim KO, Cho YK, Lee OY, Moon JS, Lee HW, Jung HY, Shin WG, Kim JG, Lee JY, Han SJ, Kim SW, Cho JH, Lim H, Kim TH, Park MI, Baik GH, Cha RR, Lee SK, Kim JJ. A Phase III, Randomized, Double-Blind, Active-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Tegoprazan for the Prevention of Peptic Ulcer in Patients on Continuous Long-Term Treatment with Nonsteroidal Anti-Inflammatory Drugs. Gut Liver. 2026 Jul 15;20(4):551-561. doi: 10.5009/gnl260057. Epub 2026 Jun 22.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Jea Jun Kim principal investigator
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lansoprazole 15 mg and Tegoprazan 25 mg in people with Preventive Peptic Ulcer, run by HK inno.N Corporation at 2 sites 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with gastric and/or duodenal ulcers at Week 24 (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04840550, which also lists 1 linked publication.
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 14 Sep 2026.