Status:
COMPLETED
Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Gastritis Acute
Gastritis Chronic
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief Summary
This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2025
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT06151210
Start Date
January 31 2024
End Date
July 15 2025
Last Update
August 28 2025
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea