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
| Registry | NCT04840550 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 392 (Actual) |
| Sponsor | HK inno.N Corporation (Industry) |
| Conditions | Preventive Peptic Ulcer |
| Interventions | Lansoprazole 15 mg, Tegoprazan 25 mg (Drug) |
| Dates | start 2021-05-07, primary completion 2025-07-01, completion 2025-07-01, first posted 2021-04-12, last updated 2026-09-14 |
| Locations | 2 sites in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Preventive Peptic Ulcer All trials of Lansoprazole 15 mg All trials of Tegoprazan 25 mg
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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Tegoprazan 25mg | Experimental | Drug: Tegoprazan 25 mg | Tegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months. |
| Lansoprazole 15mg | Active comparator | Drug: Lansoprazole 15 mg | Lansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months. |
Sex: All, ages: 20 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea | |
| The catholic univ. of Korea Eunpyeong ST. Mari's hospital | Seoul | South Korea |