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Can a new acid blocker match the standard for protecting NSAID Users' stomachs?

NCT ID NCT04840550

Prevention Sponsor: HK inno.N Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether tegoprazan 25 mg works as well as lansoprazole 15 mg at preventing stomach and duodenal ulcers in people who take NSAID pain relievers for at least six months. The trial enrolls adults aged 60 or older, or younger adults with a history of such ulcers, who need continuous NSAID treatment. Participants take one of the two drugs daily alongside their NSAIDs, and doctors check for ulcers with endoscopy at week 24. The goal is to see if tegoprazan is a safe and effective alternative for protecting the gut during long-term NSAID therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tegoprazan, an acid-suppressing drug, compared with lansoprazole
What this could lead to
If tegoprazan works as well as lansoprazole, it could offer another option for protecting the stomach in people who need long-term NSAID pain relief.
What could go wrong
The trial may show tegoprazan is not as effective as lansoprazole, or side effects may differ. Results in this specific group may not apply to everyone who takes NSAIDs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

392 people

The number who actually took part.

Started

May 2021

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

peptic ulcer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preventive peptic ulcer

Contacts and locations

Locations

  • Samsung Medical Center

    Seoul, South Korea

  • The catholic univ. of Korea Eunpyeong ST. Mari's hospital

    Seoul, South Korea

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