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The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIP2101 | Experimental | Taking HIP2101+HPP2102 once daily for 2 weeks. |
|
| RLD2101 | Active Comparator | Taking RLD21012101+HPP2101 once daily for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIP2101 | Drug | Test drug |
| |
| RLD2101 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of erosion | percentage of subjects whose erosion score is improved by more than 50% | week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate of erosion | percentage of subjects whose erosion is completely cured | week 2 |
| Cure rate of edema | percentage of subjects whose edema is completely cured |
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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 |
|---|---|---|---|
| 39949051 | Derived | Lim H, Lee JY, Kwon YH, Moon HS, Park JK, Kim KB, Kim SW, Youn YH, Kim SG, Kim GH, Kim JW, Jang JY, Kwon KS, Kwon JG, Kim HS, Hong SJ, Lee KJ, Choi SC, Moon JS, Kim N, Park JJ, Lim Y, Hong SH, Jung HY. Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study. Gut Liver. 2025 Jul 15;19(4):519-527. doi: 10.5009/gnl240390. Epub 2025 Feb 14. |
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| ID | Term |
|---|---|
| D005756 | Gastritis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| Drug |
Reference drug |
|
| HPP2101 | Drug | Placebo drug |
|
| HPP2102 | Drug | Placebo drug |
|
| week 2 |
| Improvement rate of erythema | percentage of subjects whose erythema score is improved by more than 50% | week 2 |
| Improvement rate of hemorrage | percentage of subjects whose hemorrage score is improved by more than 50% | week 2 |
| Improvement rate of GI symptoms | percentage of subjects whose GI symptoms score is improved by more than 50% | week 2 |