CompletedPhase 3

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

South Korea392 participantsStarted 2019-12-30

Plain-language 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.

Who can participate

Age range19 Years – 74 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Endoscopic Improvement Rate

Timeframe: 2 weeks

Trial details

NCT IDNCT04189705

SponsorKorea Otsuka Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-23

View on ClinicalTrials.gov More Acute Gastritis trials