Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab.

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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)

Official Title
-----------------
Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab. in Korean Patients With Acute or Chronic Gastritis in Accordance With Korean Regulation, 'Standard for Re-examination of New Drugs'

Conditions
-----------------
Acute Gastritis, Chronic Gastritis

Intervention / Treatment
-----------------
* Drug: Mucosta®SR Tablets 150mg(Rebamipide)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) in acute gastritis or acute exacerbation of chronic gastritis. Patients prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator. Patients who have given a written informed consent to participation of this PMS and use of personal information after execution of the contract with the surveillance study site. Exclusion Criteria: Patients with prior history of prescription with Mucosta®SR Tab. Patients with hypersensitivity to Rebamipide or its component ingredients. Patients deemed not suitable for surveillance enrollment according to investigator's medical judgment

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mucosta®SR Tablets 150mg(Rebamipide)|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | Presence and type of gastric symptoms at baseline and 2 weeks will be collected. | at baseline and 2 weeks |