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

Phase 3

Completed

• Conditions: Acute Gastritis; Chronic Gastritis
• Interventions: Drug: AD-203; Drug: Mucosta tab.

• Registration Number: NCT04066530
• Lead Sponsor: Addpharma Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Study Start: 2019-09-23
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

• Age is over 20 years old, under 75 years old, men or women
• Patients diagnosed with acute or chronic gastritis by gastroscopy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AD-203	AD-203	-
Mucosta tab.	Mucosta tab.	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of