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This PMS is a non-interventional, prospective, single-arm, multi-center surveillance in accordance with Korean regulation, 'Standard for Re-Examination of New Drugs'. This PMS is to assess the safety and effectiveness after administrating Mucosta®SR Tab. Each subject would be observed for 2 weeks from baseline, if possible. As this PMS is an observational study in practical medical environment, the subject's follow-up is recommended but not obligatory and must be left up to the judgment of the investigator.
According to the "Standards for Re-examination of New Drugs, etc." of South Korea, this PMS is conducted in order to collect safety and efficacy information for patients prescribed with Mucosta®SR Tab. under actual conditions of treatment during the re-examination period of Mucosta®SR Tab. 150mg (Rebamipide)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucosta®SR Tablets 150mg(Rebamipide) | Drug | adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall clinical improvement | Improved, No change, Worse The effective rate is defined as the percentage of subjects classified as 'Improved'. | at 2 weeks of treatment |
| the incidence rate and the number of cases for adverse events (AEs) | Safety information that occurred from the first administration to 3 days after discontinuation will be collected. |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic improvement rate | If upper GI endoscopy is performed at baseline and follow-up visits, the erosion score will be assessed and endoscopic improvement rate at 2 weeks will be evaluated. Endoscopic improvement rate is defined as ≥50% reduction of the erosion score. | at baseline and 2 weeks |
| Gastric symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jisu Yang | Contact | 010-3188-9178 | js.yang@otsuka.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Seoul | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| C052785 | rebamipide |
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Presence and type of gastric symptoms at baseline and 2 weeks will be collected. |
| at baseline and 2 weeks |