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OpenTrials
Completed

NCT Number: NCT04189705

A 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.

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Key information

Conditions

Acute Gastritis Chronic Gastritis

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-Ang University Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCT-SR

Drug

Rebamipide 150mg

Mucosta Tab.

Drug

Rebamipide 100mg

Other names: Mucosta

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 6, 2019
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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