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

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'

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Gastritis; Chronic Gastritis
• Intervention / Treatment: Drug: Mucosta®SR Tablets 150mg(Rebamipide)

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Jisu Yang; Phone Number: 010-3188-9178; Email: js.yang@otsuka.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Soon Chun Hyang University Hospital Seoul
    • Contact: Yumi An; Phone Number: 02-709-9222; Email: s3701@schmc.ac.kr
    • Principal Investigator: Seongran Jeon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

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

Collaborators and Investigators

• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Antioxidants; Rebamipide
• Other Study ID Numbers: 037-402-00047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No