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The study aims to demonstrate the preventive effect of Fexuprazan 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 Fexuprazan 20 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fexuprazan 20mg | Experimental | Fexuprazan 20mg orally, once daily |
|
| Lansoprazole 15mg | Active Comparator | Lansoprazole 15mg orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexuprazan 20mg | Drug | Fexuprazan 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 | From enrollment to the end of treatment at 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lee, MD, PhD | Contact | 821025858941 | 2210498@daewoong.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| Lansoprazole 15 mg placebo | Drug | Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks |
|
| Lansoprazole 15 mg | Drug | Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks |
|
| Fexuprazan 20mg placebo | Drug | Fexuprazan 20mg placebo-matching tablet, orally, once daily for up to 24 weeks |
|
| ID | Term |
|---|---|
| C000634065 | fexuprazan |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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