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

Recruiting

• Conditions: Chronic Gastritis; Acute Gastritis

• Registration Number: NCT05048069
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

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 Timeline

• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-17
• Study Start: 2021-10-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall clinical improvement	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)	Safety information that occurred from the first administration to 3 days after discontinuation will be collected.

Secondary Outcome Measures

Name	Time	Method
Endoscopic improvement rate	at baseline and 2 weeks	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.
Gastric symptoms	at baseline and 2 weeks	Presence and type of gastric symptoms at baseline and 2 weeks will be collected.

Trial Locations

Locations (1)

Soon Chun Hyang University Hospital Seoul; 🇰🇷 Seoul, Korea, Republic of