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

Launched by KOREA OTSUKA PHARMACEUTICAL CO., LTD. · Sep 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Mucosta®SR Tab for patients with conditions like acute gastritis and chronic gastritis. Gastritis refers to inflammation of the stomach lining, which can cause symptoms such as stomach pain and nausea. The trial is open to adult patients who have certain types of damage to their stomach lining, such as erosion or redness, and who have been prescribed Mucosta®SR Tab by their doctor. To participate, patients need to provide written consent to allow their information to be used in the study.

Participants in this study will be monitored for two weeks after starting the medication. While follow-up visits are encouraged, they are not mandatory and will be based on the doctor's judgment. The trial is currently recruiting patients of all genders and ages starting from 39 years old. It's important to note that individuals who have previously taken Mucosta®SR Tab, those with allergies to its ingredients, or those deemed unsuitable by their doctor cannot participate. This study aims to gather real-world information about how well the medication works and how safe it is for patients.

Gender

ALL

Eligibility criteria

• 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