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

Phase 3

Completed

• Conditions: Acute Gastritis; Chronic Gastritis
• Interventions: Drug: MCT-SR; Drug: Mucosta Tab.

• Registration Number: NCT04189705
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-06
• Study Start: 2019-12-30
• Primary Completion: 2020-04-23
• Study Completion: 2020-04-23
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCT-SR	MCT-SR	Drug: MCT-SR 2 times/day for 2 weeks
Mucosta Tab.	MCT-SR	Drug: Mucosta Tab. 3 times/day for 2 weeks
MCT-SR	Mucosta Tab.	Drug: MCT-SR 2 times/day for 2 weeks
Mucosta Tab.	Mucosta Tab.	Drug: Mucosta Tab. 3 times/day for 2 weeks

Primary Outcome Measures

Name	Time	Method
Endoscopic Improvement Rate	2 weeks	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.

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of