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

March 10, 2021 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCT-SR
Drug: MCT-SR 2 times/day for 2 weeks
Drug: MCT-SR
Rebamipide 150mg
Drug: Mucosta Tab.
Rebamipide 100mg
Other Names:
  • Mucosta
Active Comparator: Mucosta Tab.
Drug: Mucosta Tab. 3 times/day for 2 weeks
Drug: MCT-SR
Rebamipide 150mg
Drug: Mucosta Tab.
Rebamipide 100mg
Other Names:
  • Mucosta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic Improvement Rate
Time Frame: 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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: JaeGyu Kim, Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2019

Primary Completion (Actual)

April 23, 2020

Study Completion (Actual)

April 23, 2020

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 037-402-00039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Gastritis

Clinical Trials on MCT-SR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe