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The study aims to demonstrate the preventive effect of DWP14012 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 DWP14012 20 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP14012 20mg | Experimental | orally, once daily |
|
| Lansoprazole 15mg | Active Comparator | orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 20mg | Drug | DWP14012 20mg, tablet, orally, once daily for up to 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator | at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator | at 12 weeks | |
| Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24 | at 12, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40567214 | Derived | Hong S, Ju JH, Lee SH, Hong SJ, Kim SH, Ahn GY, Jung JH, Hur JW, Ha YJ, Park JK, Kim HS, Lee SW, Park YB, Lim MJ, Kim YS, Song JS, Choi CB, Kim SH, Choi IA, Choi KD, Lee TH, Cho YS, Lee YC, Kwon KS, Lee H, Park M, Heo J, Baek S, Lee CK. Comparing the Efficacy and Safety of Fexuprazan and Lansoprazole for the Prevention of Nonsteroidal Anti-inflammatory Drug-Induced Peptic Ulcer. Gut Liver. 2025 Sep 15;19(5):685-695. doi: 10.5009/gnl250019. Epub 2025 Jun 26. |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000634065 | fexuprazan |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Lansoprazole 15 mg |
| Drug |
Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks |
|
| DWP14012 20mg placebo | Drug | DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks |
|
| Lansoprazole 15 mg placebo | Drug | Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks |
|
| D013272 | Stomach Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |