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The purpose of this study is to evaluate the efficacy and safety by comparing prevention of recurrent peptic ulcer in low-dose aspirin users between PMK-S005 and Placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo Comparator / Bid |
|
| PMK-S005 1 | Experimental | Total 50mg, by mouth, bid |
|
| PMK-S005 2 | Experimental | Total 100mg, by mouth, bid |
|
| PMK-S005 3 | Experimental | Total 150mg, by mouth, bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Drug : Placebo |
| |
| PMK-S005 1 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of endoscopic peptic ulcer | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer) | 12 weeks | |
| The incidence of endoscopic stomach / duodenal erosion | 12 weeks | |
| The incidence of endoscopic stomach / duodenal ulcer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang Seoul University Hospital | Kumi-dong | Bundang-gu, Seongnam-si, Gyeonggi-do | 463-707 | South Korea |
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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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| Drug |
Drug : PMK-S005 1 (50mg) |
|
| PMK-S005 2 | Drug | Drug : PMK-S005 2 (100mg) |
|
| PMK-S005 3 | Drug | Drug : PMK-S005 3 (150mg) |
|
| 12 weeks |
| The changes of MLS in the gastroduodenal endoscopy result compared to baseline | 12 weeks |
| The incidence of endoscopic esophagitis | 16 weeks |
| Rescue drug use count and the total amount | 16 weeks |
| Changes in gastrointestinal symptoms score | 16 weeks |
| D013272 | Stomach Diseases |