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This study aims to evaluate the improvement effect on subjective symptoms of gastritis and adverse events through patient self-assessment results (PRO) by conducting follow-up observations for patients with gastritis at 2 to 4 weeks after administration of Mucotra® SR tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucotra® SR Tab | Mucotra® SR Tab Rebamipide 150mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in total subjective symptom score compared to baseline | Change in total subjective symptom score compared to baseline at 2 weeks (up to 4 weeks) on a scale of 0 to 3 points for 8 items (epigastric pain, severe pain, nausea/vomiting, acid reflux, bloating, poor appetite, heartburn, burping). Higher scores are indicative of more severe symptoms. | 2 weeks (up to 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in individual subjective symptom score compared to baseline | Change in individual subjective symptom score compared to baseline at 2 weeks (up to 4 weeks) on a scale of 0 to 3 points for 8 items (epigastric pain, severe pain, nausea/vomiting, acid reflux, bloating, poor appetite, heartburn, burping). Higher scores are indicative of more severe symptoms. | 2 weeks (maximum 4 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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The minimum number of study subjects required to estimate the two-sided 95% confidence interval of the change in the total score of subjective symptoms at 2 weeks compared to the baseline as -3.19 to 2.99, with the standard deviation assumed by referring to the AD-203P3 literature, is calculated to be 15,247 ( PASS 13. NCSS, LLC. (Kailsville, Utah, USA)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Song Kwang Seon Internal medicine clinic | Wŏnju | South Korea |
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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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| The effective rate of subjective symptoms compared to baseline | The effective rate of subjective symptoms compared to baseline at 2 weeks (maximum 4 weeks). The effective rate is the percentage of patients whose total subjective symptom scores are reduced by more than 50% compared to their scores before administration. | 2 weeks (maximum 4 weeks) |
| Overall change assessed by study subjects after administration of the study drug | Overall change assessed by study subjects after administration of the study drug at 2 weeks. (maximum 4 weeks) The overall change is assessed using five criteria: very much improved, much improved, minimally improved, no change, and worse. | 2 weeks (maximum 4 weeks) |
| Overall change assessed by the researcher after administration of the drug under study | Overall change assessed by the researcher after administration of the drug under study at 2 weeks (maximum 4 weeks). The overall change is assessed using five criteria: very much improved, much improved, minimally improved, no change, and worse. | 2 weeks (maximum 4 weeks) |
| Adverse events that occurred after administration of Mucotra® extended-release tablets | Adverse events that occurred after administration of Mucotra® extended-release tablets at 2 weeks (maximum 4 weeks) | 2 weeks (maximum 4 weeks) |