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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000002901 | Other Identifier | Japan: Infrastructure for Academic Activities, University hospital Medical Information Network |
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| Name | Class |
|---|---|
| Gastro-Intestinal Medical Care Research Center | UNKNOWN |
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The aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection.
The events of recurrence of gastric and/or duodenal ulcers will be evaluated due to a blinded manner by specialized endoscopists at pre- and post administration during 12 weeks administration of PPI (Rabeprazole sodium 10 mg or 20 mg tablet once a day) or the mucosal defensive drug (Gefarnate 50mg Capsule twice a day).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Low-dose PPI (Rabeprazole sodium 10 mg) |
|
| Group II | Active Comparator | High-dose PPI (Rabeprazole sodium 20 mg) |
|
| Group III | Active Comparator | Non-PPI (Gefarnate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose PPI (Rabeprazole sodium) | Drug | PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Recurrence of Gastric and/or Duodenal Ulcers | 12 weeks after giving medication |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events | 12 weeks after giving medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Azuma, M.D., Ph.D. | Kobe University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe University, School of Medicine | Kobe | Hyōgo | 650-0017 | Japan |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| D005778 | Gefarnate |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| High-dose PPI (Rabeprazole sodium) | Drug | PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three) |
|
| Non-PPI (Gefarnate) | Drug | The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three) |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |