A Study to Evaluate the Efficacy and Safety of AD-203

Addpharma Inc.475 enrolled

Overview

This is a multicenter, active-controlled , randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of AD-203 to demonstrate the non-inferiority of AD-203 compared with Mucosta tab. in patients with acute or chronic gastritis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

475

Conditions

Acute Gastritis Chronic Gastritis

Interventions

AD-203DRUG

AD-203 administered two times daily for two weeks

Mucosta tab.DRUG

Mucosta tab. administered three times daily for two weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age is over 20 years old, under 75 years old, men or women * Patients diagnosed with acute or chronic gastritis by gastroscopy Exclusion Criteria: * Patients who is impossible to receive gastroscopy * Patients taking other investigational drugs or participating in other clinical studies in 3 months prior to screening visit

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

A percentage of subjects showed improvement of stomach erosions by the endoscopy.

Evaluate the improvement rate of "Very much improved' and "Much improved" of subjects with stomach erosions. The definition of "Very Much Improved" is the subjects showed score changed from 4 to 1 or from 3 to 1. And, "Much improved" means the subject showed score changed from 4 to 2 or from 2 to 1.

Time frame: 2 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.