Overview

Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis

Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dong-A ST Co., Ltd.
Criteria
Main Inclusion Criteria:

- Men or women aged ≥ 19 years and ≤ 75 years

- Subjects who diagnosed with acute or chronic gastritis by upper gastrointestinal
endoscopy within 7days prior to the randomization

- Subjects who have one or more erosions identified on upper gastrointestinal endoscopy
within 7days prior to the randomization

- Subjects who voluntarily signed a consent form

Main Exclusion Criteria:

- Ineligible for upper gastrointestinal endoscopy

- Subjects with active or healing gastroduodenal ulcer, reflux esophagitis, Barrett's
esophagus, or gastroesophageal varices identified on upper gastrointestinal endoscopy
within 7days prior to the randomization

- Subjects with hypersensitivity to investigational drugs and similar drugs

- Pregnant or breastfeeding women