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
Overview
- Phase
- Phase 3
- Intervention
- MCT-SR
- Conditions
- Acute Gastritis
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Enrollment
- 392
- Locations
- 1
- Primary Endpoint
- Endoscopic Improvement Rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Arms & Interventions
MCT-SR
Drug: MCT-SR 2 times/day for 2 weeks
Intervention: MCT-SR
MCT-SR
Drug: MCT-SR 2 times/day for 2 weeks
Intervention: Mucosta Tab.
Mucosta Tab.
Drug: Mucosta Tab. 3 times/day for 2 weeks
Intervention: MCT-SR
Mucosta Tab.
Drug: Mucosta Tab. 3 times/day for 2 weeks
Intervention: Mucosta Tab.
Outcomes
Primary Outcomes
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.