Acute Gastritis, Chronic Gastritis
Conditions
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.
Interventions
DRUGMCT-SR
Rebamipide 150mg
DRUGMucosta Tab.
Rebamipide 100mg
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic Improvement Rate | 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. |
Countries
South Korea
Outcome results
None listed