The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
263
DWP14012 40mg, tablet, orally, once daily for up to 8 weeks
DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks
Hanyang University Medical Center
Seoul, South Korea
Cumulative healing rate of erosive esophagitis at 8week by endoscopy
Time frame: at 8week
Cumulative healing rate of erosive esophagitis at 4week by endoscopy
Time frame: at 4week
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Mean change of the frequency or severity of main symptoms
Time frame: at 4week and 8week
Quality of Life assessment using GERD-HRQL(GERD-Health related quality life)
Mean change of the total score of GERD-HRQL
Time frame: at 4week and 8week
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Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks