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A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIP0612 | Experimental | Taking HIP0612+HPP2202 once daily for 4 or 8 weeks. |
|
| RLD2204 | Active Comparator | Taking RLD2204+HPP2201 once daily for 4 or 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIP0612 | Drug | Test drug |
| |
| HPP2202 |
| Measure | Description | Time Frame |
|---|---|---|
| Healing rate of gastric ulcer | Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Healing rate of gastric ulcer | week 4 | |
| Healing rate of gastric ulcer according to H.pylori infection status | week 4, 8 | |
| Post-treatment resolution rate of GI symptoms |
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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 |
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| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Drug |
Placebo drug |
|
| RLD2204 | Drug | Reference drug |
|
| HPP2201 | Drug | Placebo drug |
|
| week 4, 8 |
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |