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

Korea Otsuka Pharmaceutical Co., Ltd.600 enrolled

Overview

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.

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

600

Conditions

Acute Gastritis Chronic Gastritis

Interventions

Mucosta®SR Tablets 150mg(Rebamipide)DRUG

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Overall clinical improvement

Improved, No change, Worse The effective rate is defined as the percentage of subjects classified as 'Improved'.

Time frame: at 2 weeks of treatment

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

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.

Time frame: at baseline and 2 weeks

Gastric symptoms

Presence and type of gastric symptoms at baseline and 2 weeks will be collected.

Time frame: at baseline and 2 weeks

Central Contacts

Jisu Yang

CONTACT

010-3188-9178 js.yang@otsuka.co.kr

Data from ClinicalTrials.gov

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