Acute Gastritis, Chronic Gastritis
Conditions
Brief summary
This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.
Interventions
DRUGDA-5204
DRUGStillen tab.
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
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age is over 20 years old, under 75 years old, men or women * Patients diagnosed with acute or chronic gastritis by gastroscopy * Patients with one or more erosions found by gastroscopy * Signed the informed consent forms
Exclusion criteria
* Patients who is impossible to receive gastroscopy * Patients with peptic ulcer and gastroesophageal reflux disease * Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks * Patients with surgery related to gastroesophageal * Patients with Zollinger-Ellison syndrome * Patients with any kind of malignant tumor * Patients administered with anti-thrombotic drugs * Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease * Patients with neuropsychiatric disorder, alcoholism, or drug abuse * Patients taking other investigational drugs or participating in other clinical studies in 4 weeks. * Women either pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy. | 2 weeks | The definition of moderate improvement is the subjects showed score changed from 4 to 1 or from 2 to 1. And, significant improvement means the subject showed score changed from 4 to 1 or from 3 to 1. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A percentage of completely cured subject after a treatment | 2 weeks | The definition of completely cured is the subjects with no erosions, in other words, 0 erosion found at stomach by the endoscopy. |
| A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale. | 2 weeks | The definition of moderate improvement is the subjects showed reduction ratio of score changed from 50% to 75%. And, singnificant improvement means the subjects showed reduction ratio of score changed 75% or more. Reduction ratio of score is calculated as \[1-(total score of 7 days before termination of treatment)/(total score of 7 days before treatment)\]. |
Countries
South Korea
Outcome results
None listed