The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.
This is a multi-center, double blind, randomized, placebo-controlled, parallel-group, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (DWP14012 A mg or DWP14012 B mg or placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
327
The participants will receive treatment of DWP14012 A mg, tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.
The participants will receive treatment of DWP14012 B mg, tablet, orally, once daily and DWP14012 A mg placebo-matching tablet, orally, once daily for up to 4 weeks.
The participants will receive treatment of DWP14012 A mg placebo-matching tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.
Hanyang University Medical Center
Seoul, South Korea
RECRUITING1. Percentage of patients with complete resolution of major symptoms (heartburn and acid 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
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Time frame: 2 week, 4 week
Reflux disease symptom assessment using Subject diary
Time frame: 4 week
Quality of Life assessment using PAGI-QoL
Time frame: 4 week
Use of rescue medication
Time frame: 4 week
Daewoong Pharmaceutical Co. LTD.
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