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| Name | Class |
|---|---|
| Zhejiang Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
| Korea Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the ulcer healing efficacy of rebamipide in comparison with omeprazole in Helicobacter pylori-positive gastric ulcer after eradication therapy.
This study is designed to evaluate the ulcer healing efficacy of rebamipide administered following the eradication therapy in comparison with the well known PPI, omeprazole. This is a double-blind, comparative study which is expected to prove the role of rebamipide in gastric ulcer healing after the eradication therapy. This study may contribute to further clinical research on a new type of ulcer treatment by looking at the treatment modality based on the enhancement of defensive factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rebamipide | Experimental |
|
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| Omeprazole | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebamipide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric ulcer healing rate | Rebamipide showed 81.5~87.8% of gastric ulcer healing rate which was not inferior to 82.5~87.8% healing rate of Omeprazole. | at 12 weeks after the initial administration of the study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.) | at 12 weeks after the initial administration of the study medication | |
| Serum gastrin level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Ho Kim, M.D. | Asan Medical Center, Ulsan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Affiliated hospital - Zhongshan Univ. | Guangzhou | Guangdong | 510080 | China | ||
| Nanfang Hospital - Nanfang Medical Univ. |
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|
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| Omeprazole | Drug |
5-melthoxy-2-{{{4-melthoxy-3.5-dlmethyl2-pyridinyl}methyl}sulp- hinyl}-1H-benzimidazole sodium. 4) Formulation: Capsule. 5) Strength: One capsule contains omeprazole 20mg. 6) Storage condition: 15℃~25℃. 7) Manufacturer: AstraZenaca Korea. |
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| at 8 and 12 weeks after the initial administration of study medication |
| Economical efficiency | Rebamipide was more cost effective than Omeparzole for 7 weeks of gastric ulcer treatment. | drug cost/effect ratio |
| Guangzhou |
| Guangdong |
| 510515 |
| China |
| Xijing Hospital - The 4th Military Medical Univ | Xi’an | Shanxi | 710032 | China |
| The 1st Affiliated Hospital - Medical School of Zhejiang Univ. | Hangzhou | Zhejiang | 310003 | China |
| Ren-Ji Hospital - Shanghai Second Medical Univ. | Shanghai | 200001 | China |
| Korea University Ansan Hospital | Ansan | 425-707 | South Korea |
| Severance Hospital, Seoul National University | Seoul | 120-752 | South Korea |
| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C052785 | rebamipide |
| D009853 | Omeprazole |
| 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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