The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
213
Asan Medical Center
Seoul, South Korea
Complete healing rate
percentage of subjects whose erosion is completely cured
Time frame: at 4 weeks or 8 weeks
Complete healing rate
percentage of subjects whose erosion is completely cured
Time frame: at 4 weeks
Complete resolution rate of each symptom in GERD
Time frame: at 4,8 weeks
Proportion of heartburn-free days, acid regurgitation-free days
Time frame: at 1, 2, 4, 8 weeks
Proportion of heartburn-free nights, acid regurgitation-free nights
Time frame: at 1, 2, 4, 8 weeks
Time to sustained resolution heartburn, acid regurgitation
Time frame: at 4 weeks or 8 weeks
Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation
Time frame: at 4 weeks or 8 weeks
Total number of use of relief drugs and average usage per day
Time frame: at 4 weeks or 8 weeks
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Oral Placebo