Gastritis Chronic Clinical Trial
Official title:
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
This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis
| Status | Recruiting |
| Enrollment | 452 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Asan Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Dong-A ST Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement rate of gastric mucosal erosion | Change from baseline at 2 weeks | ||
| Secondary | Cure rate for gastric mucosal erosion | Change from baseline at 2 weeks | ||
| Secondary | Cure rate for gastric mucosal edema | Change from baseline at 2 weeks | ||
| Secondary | Improvement rate for gastric mucosal erythema | Change from baseline at 2 weeks | ||
| Secondary | Improvement rate for gastric mucosal bleeding | Change from baseline at 2 weeks | ||
| Secondary | Improvement rate for gastric subjective symptoms | Change from baseline at 2 weeks |
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