A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis

Korea Otsuka Pharmaceutical Co., Ltd.392 enrolled

Overview

This is a multi-center, randomized, double-blind, active-controlled, non-inferiority, phase 3 study to evaluate the efficacy and safety of MCT-SR in patients with gastritis.

To contribute greater treatment compliance and patient convenience, the rebamipide SR formulation has been developed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

392

Conditions

Acute Gastritis Chronic Gastritis

Interventions

MCT-SRDRUG

Rebamipide 150mg

Mucosta Tab.DRUG

Rebamipide 100mg

Eligibility

Sex: ALLMin age: 19 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult males and females aged ≥19 and \<75 years * Patients diagnosed with acute or chronic gastritis by gastroscopy with at least 1 erosion confirmed by gastroscopy within 7 days prior to the first dose of the Investigational Product(IP) Exclusion Criteria: * Patients ineligible for gastroscopy * Patients who took other drugs for treating gastritis within 2 weeks prior to the first dose of the IP. * Patients who have to continue taking drugs that may induce gastritis * Other clinically significant medical or psychiatric findings that the investigator considers inappropriate for the study

Locations (1)

Chung-Ang University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Endoscopic Improvement Rate

The percentage of subjects with improvement refer to those with more than 50% improvement in erosion score on gastroscopy after treatment compared to the score before treatment.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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