This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
492
Seoul National University Hospital
Seoul, South Korea
RECRUITINGThe number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal).
The scale is classified into 5 steps which are based on the severity of the improvement. EX) noticable improvement: 4-\>1, 3-\>1, slight improvement: 4-\>3, 3-\>2
Time frame: 2 weeks
The number of erosions diagnosed by the gastroscope
Time frame: 2 weeks
The severity of the digestive symptoms (Scale of 1 to 5)
the example of the symptoms are: epigastralgia, heartburn, acid reflux, nausea, domperidone
Time frame: 2 weeks
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