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'
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Overall clinical improvement
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)
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Overall clinical improvement
Time Frame: at 2 weeks of treatment
Improved, No change, Worse The effective rate is defined as the percentage of subjects classified as 'Improved'.
the incidence rate and the number of cases for adverse events (AEs)
Time Frame: Safety information that occurred from the first administration to 3 days after discontinuation will be collected.
Secondary Outcomes
- Endoscopic improvement rate(at baseline and 2 weeks)
- Gastric symptoms(at baseline and 2 weeks)