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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
434
Seoul National Universtiy, Bundang Hospital, IRB
Seongnam-si, Gyeonggi-do, South Korea
A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.
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. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\]
Time frame: 2 weeks
A percentage of completely cured subject after a treatment
The definition of "completely cured" is the subjects with no erosions, in other words, 0 erosion found at stomach by the endoscopy.
Time frame: 2 weeks
A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale.
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 \[1-(total score of 7 days before termination of treatment)/(total score of 7 days before treatment)\].
Time frame: 2 weeks
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