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'

037-402-00047

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.

2021-10-07

2024-12-15

2024-12-15

Recruiting

600

Inclusion Criteria: 1. Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) in acute gastritis or acute exacerbation of chronic gastritis. 2. Patients prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator. 3. 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: 1. Patients with prior history of prescription with Mucosta®SR Tab. 2. Patients with hypersensitivity to Rebamipide or its component ingredients. 3. Patients deemed not suitable for surveillance enrollment according to investigator's medical judgment

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

2023-09-28