A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis

DA5219_GAS_III

This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis

2024-01-31

2024-12-01

2024-12-01

Recruiting

Early phase I

452

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 452, 'type': 'ESTIMATED'}}

2024-04-04