This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.
After filling an Informed consent form, subjects are joined the clinical trials. First of all, Screening test including the endoscopy test is performed. Subjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes investigation products as randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
520
Inje University Busan Paik Hospital
Busan, South Korea
the percentage of protected subjects (%)
the definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at stomach by the endoscopy.
Time frame: 4 weeks
A percentage of a protected subject (at duodenum), and of ulcer occurrence
1. The definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at duodenum by the endoscopy. 2. A percentage of ulcer occurrence
Time frame: 4 weeks
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