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To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebamipide | Drug | Rebamipide 100㎎, 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of gastric ulcer on gastroendoscopy result at 12-week | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Therapeutic failure | 12 weeks | |
| Severity of gastrointestinal symptoms | 12 weeks | |
| Antacid consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo-Heon Park, MD PhD | Catholic University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon-si | South Korea | |||||
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| Misoprostol | Drug | Misoprostol 200㎍ 12 weeks |
|
|
| 12 weeks |
| Daegu |
| South Korea |
| Daejeon | South Korea |
| Gwangju | South Korea |
| Incheon | South Korea |
| Jeonju | South Korea |
| Jinju | South Korea |
| Pusan | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
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| ID | Term |
|---|---|
| C052785 | rebamipide |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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