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

Addpharma

Status and phase: Completed; Phase 3

Conditions: Chronic Gastritis; Acute Gastritis

Treatments: Drug: AD-203; Drug: Mucosta tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04066530

AD-203P3

Details and patient eligibility

About

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

Enrollment: 475 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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475 participants in 2 patient groups

AD-203

Experimental group

Treatment:

Drug: AD-203

Mucosta tab.

Active Comparator group

Treatment:

Drug: Mucosta tab.