The purpose of this study is to demonstrate the superiority of efficacy of CJ-12420, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4
This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg or 100 mg or placebo). All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daily symptom in a subject diary on a daily basis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
324
CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks
CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks
Placebo, tablet, once daily, oral administration for up to 4 weeks
Yeouido St.Mary's Hospital
Seoul, South Korea
Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation) at 4-week, defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)
Time frame: 4 week
Resolution of main symptoms(heartburn and regurgitation) at 2-week(for 7 consecutive days)
Time frame: 2 week
RDQ score change
Time frame: 4 week
Percentage of symptom free days
Symptom will be collected by patient diary.
Time frame: 4 week
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