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

NCT ID: NCT04189705

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-30

Study Completion Date

2020-04-23

Brief Summary

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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

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

Conditions

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Acute Gastritis Chronic Gastritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MCT-SR

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

Group Type EXPERIMENTAL

MCT-SR

Intervention Type DRUG

Rebamipide 150mg

Mucosta Tab.

Intervention Type DRUG

Rebamipide 100mg

Mucosta Tab.

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

Group Type ACTIVE_COMPARATOR

MCT-SR

Intervention Type DRUG

Rebamipide 150mg

Mucosta Tab.

Intervention Type DRUG

Rebamipide 100mg

Interventions

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MCT-SR

Rebamipide 150mg

Intervention Type DRUG

Mucosta Tab.

Rebamipide 100mg

Intervention Type DRUG

Other Intervention Names

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Mucosta

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JaeGyu Kim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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037-402-00039

Identifier Type: -

Identifier Source: org_study_id

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