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NCT04066530 Clinical Trial

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

Chronic Gastritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04066530
Other study ID # AD-203P3
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 23, 2019
Est. completion date February 26, 2020

Study information
Verified date December 2020
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 475
Est. completion date February 26, 2020
Est. primary completion date February 26, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AD-203
AD-203 administered two times daily for two weeks
• Mucosta tab.
Mucosta tab. administered three times daily for two weeks

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.		 2 weeks
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