NCT04189705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

December 30, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2020

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

November 25, 2019

Last Update Submit

March 10, 2021

Conditions

Acute GastritisChronic Gastritis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

MCT-SR

EXPERIMENTAL

Drug: MCT-SR 2 times/day for 2 weeks

Drug: MCT-SRDrug: Mucosta Tab.

Mucosta Tab.

ACTIVE COMPARATOR

Drug: Mucosta Tab. 3 times/day for 2 weeks

Drug: MCT-SRDrug: Mucosta Tab.

Interventions

MCT-SRDRUG

Rebamipide 150mg

MCT-SRMucosta Tab.
Mucosta Tab.DRUG

Rebamipide 100mg

Also known as: Mucosta
MCT-SRMucosta Tab.

Eligibility Criteria

Age19 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-Ang University Hospital

Seoul, South Korea

Location

Study Officials

  • JaeGyu Kim, Ph.D.

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 6, 2019

Study Start

December 30, 2019

Primary Completion

April 23, 2020

Study Completion

April 23, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)