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

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

Completed

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Key information

Conditions

Acute Gastritis Chronic Gastritis

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Guro Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AD-203

Drug

AD-203 administered two times daily for two weeks

Mucosta Tab.

Drug

Mucosta tab. administered three times daily for two weeks

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.

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Aug 26, 2019
Registry last updated: Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed