Gastritis
Conditions
Brief summary
The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis.
Interventions
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 19≤ age ≤ 75 * Have been diagnosed as acute or chronic gastritis with at least 1 erosion by endoscopy within 7 days before enrollment. * Patients understood the consents and purpose of this trial and signed consent form
Exclusion criteria
* Patients who cannot perform endoscopy * Active gastric or duodenal ulcer * Reflux esophagitis, barrett's esophagus, gastric or esophageal varix * Zollinger-Ellison syndrome, pyloric obstruction, and esophageal stricture, Inflammatory Bowel Diease, acute pancreatitis * History of gastrointestinal surgery * History of malignancy tumor, especially in the upper gastrointestinal tract * Severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range) * Severe renal disorder(at screening day, MDRD eGFP ≤ 30 mL/min/1.73m2) or chronic renal disease * Bleeding disorder * Patients who have taken drugs containing following list within 2 weeks before endoscopy : H2-receptor antagonists, Proton pump inhibitors, P-CABs, gastrin inhibitors, antacids, gastric mucosal protectants, anticholinergics * Patients who have taken anticoagulants within a week before endoscopy * Patients who have taken drugs containing following list after endoscopy : GI tract regulators, salicylates, steroids, , NSAIDs, bisphosphonates, selective serotonin reuptake inhibitors, iron supplements, oriental herbal medicines * History of allergic reaction to the medications used in this study * Use of other investigational drugs within 30 days prior to the study * History of alcohol or drug abuse * Positive to pregnancy test, nursing mother, intention on pregnancy * Considered by investigator as not appropriate to participate in the clinical study with other reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement rate of erosion | week 2 | percentage of subjects whose erosion score is improved by more than 50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate of erosion | week 2 | percentage of subjects whose erosion is completely cured |
| Cure rate of edema | week 2 | percentage of subjects whose edema is completely cured |
| Improvement rate of erythema | week 2 | percentage of subjects whose erythema score is improved by more than 50% |
| Improvement rate of hemorrage | week 2 | percentage of subjects whose hemorrage score is improved by more than 50% |
| Improvement rate of GI symptoms | week 2 | percentage of subjects whose GI symptoms score is improved by more than 50% |
Countries
South Korea
Outcome results
None listed