Acute and Chronic Gastric Inflammation Patients
Conditions
Brief summary
The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.
Interventions
DRUGDW-3101_150mg
DRUGDW-3101_300mg
DRUGDW-3101_600mg
DRUGPlacebo
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult males/females aged 20\ 75 years * Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents * Subjects who voluntarily agree to participate in this clinical test with written consent
Exclusion criteria
* Patients impossible gastroscopy * In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis * Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded) * Patients with malignant tumor on digestive organ * Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of gastric erosion score | 14day±3 | The erosion score is evaluated by gastroscopy. Erosion score The number of erosion 1. 0 2. 1\ 2 3. 3\ 5 4. More than 6 If patient's erosion score is decreased by 50% compared with erosion score before clinical dosing, we count it as effectiveness. |
Outcome results
None listed