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NCT04189705 Clinical Trial

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

Chronic Gastritis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04189705
Other study ID # 037-402-00039
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 30, 2019
Est. completion date April 23, 2020

Study information
Verified date March 2021
Source Korea Otsuka Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 392
Est. completion date April 23, 2020
Est. primary completion date April 23, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 74 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• MCT-SR
Rebamipide 150mg
• Mucosta Tab.
Rebamipide 100mg

Locations
Country Name City State
Korea, Republic of Chung-Ang University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 2 weeks
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