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

• Status: Completed
• Trial end date: 2020-04-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

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