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The sutdy aims to to demonstrate the non-inferiority of JP-1366 10 mg compared to Lanston Capsule 15 mg in preventing NSAIDs-induced peptic ulcers and to compare/evaluate the efficacy and safety of JP-1366 10 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JP-1366 10 mg | Experimental |
| |
| Lanston Capsule 15 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JP-1366 10 mg | Drug | JP-1366 10 mg, tablet, orally once a day for up to 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative proportion of subjects who developed peptic ulcers | at 24 weeks after administration of investigational products |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with gastric or duodenal endoscopic bleeding | at 24 weeks after administration of investigational products |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John KIM | Contact | 0234540780 | onconictherapeutics@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Recruiting | Seoul | 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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| Lanston Capsule 15 mg |
| Drug |
Lanston Capsule 15 mg orally once a day for up to 24 weeks |
|
| JP-1366 10 mg placebo | Drug | JP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks |
|
| Lanston Capsule 15 mg placebo | Drug | Lanston Capsule 15 mg placebo, orally once a day for up to 24 weeks |
|
| D013272 | Stomach Diseases |