Gastritis Acute, Gastritis Chronic
Conditions
Brief summary
This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis
Interventions
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of gastric mucosal erosion | Change from baseline at 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Cure rate for gastric mucosal erosion | Change from baseline at 2 weeks |
| Cure rate for gastric mucosal edema | Change from baseline at 2 weeks |
| Improvement rate for gastric mucosal erythema | Change from baseline at 2 weeks |
| Improvement rate for gastric mucosal bleeding | Change from baseline at 2 weeks |
| Improvement rate for gastric subjective symptoms | Change from baseline at 2 weeks |
Countries
South Korea
Outcome results
None listed