A Randomized, Double-blinded, Active Controlled, Non-Inferiority, Multicenter, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AD-203 in Patients With Acute or Chronic Gastritis

Addpharma Inc.1 site in 1 country475 target enrollmentSeptember 23, 2019

ConditionsAcute Gastritis Chronic Gastritis

InterventionsAD-203 Mucosta tab.

DrugsAD-203 Mucosta tab.

Overview

Phase: Phase 3
Intervention: AD-203
Conditions: Acute Gastritis
Sponsor: Addpharma Inc.
Enrollment: 475
Locations: 1
Primary Endpoint: A percentage of subjects showed improvement of stomach erosions by the endoscopy.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 23, 2019

End Date

February 26, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Addpharma Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

AD-203

Intervention: AD-203

Mucosta tab.

Intervention: Mucosta tab.

Outcomes

Primary Outcomes

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

Time Frame: 2 weeks

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.