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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegoprazan 25mg | Experimental | Tegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months. |
|
| Lansoprazole 15mg | Active Comparator | Lansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole 15 mg | Drug | Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week 4, 12, 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yugyeong Park | Contact | 82-2-6477-0269 | yugyeong.park@inno-n.com | |
| Jiwon Lee | Contact | 82-2-6477-0273 | jiwon.lee@inno-n.com |
| Name | Affiliation | Role |
|---|---|---|
| Jea Jun Kim | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42325011 | Derived | 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 Jun 22. doi: 10.5009/gnl260057. Online ahead of print. |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| C000631239 | tegoprazan |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Tegoprazan 25 mg | Drug | Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months. |
|
| The catholic univ. of Korea Eunpyeong ST. Mari's hospital | Recruiting | Seoul | South Korea |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |