Back to resultsA Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
Primary Purpose
Acute Gastritis, Chronic Gastritis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MCT-SR
Mucosta Tab.
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gastritis
Eligibility Criteria
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
Sites / Locations
- Chung-Ang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MCT-SR
Mucosta Tab.
Arm Description
Drug: MCT-SR 2 times/day for 2 weeks
Drug: Mucosta Tab. 3 times/day for 2 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04189705
First Posted
November 25, 2019
Last Updated
March 10, 2021
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04189705
Brief Title
A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
April 23, 2020 (Actual)
Study Completion Date
April 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
To contribute greater treatment compliance and patient convenience, the rebamipide SR formulation has been developed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastritis, Chronic Gastritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
392 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MCT-SR
Arm Type
Experimental
Arm Description
Drug: MCT-SR 2 times/day for 2 weeks
Arm Title
Mucosta Tab.
Arm Type
Active Comparator
Arm Description
Drug: Mucosta Tab. 3 times/day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
MCT-SR
Intervention Description
Rebamipide 150mg
Intervention Type
Drug
Intervention Name(s)
Mucosta Tab.
Other Intervention Name(s)
Mucosta
Intervention Description
Rebamipide 100mg
Primary Outcome Measure Information:
Title
Endoscopic Improvement Rate
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JaeGyu Kim, Ph.D.
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
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