Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non Erosive Reflux Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease

Conditions
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Non-Erosive Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: DWP14012 A mg
* Drug: DWP14012 B mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged between 20 and 75 years Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD Subjects who had experienced major symptom within 3 months Subjects who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week Subjects who is able to understand and follow the instructions Subjects who voluntarily signed written informed consent form Exclusion Criteria: Subjects who have Barrett's esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by endoscopy Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers within 2 months before Visit 1 Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD in the last 3 months Subjects who have a history of gastric acid suppression surgery or gastroesophageal surgery Subjects with Zollinger-Ellison syndrome Subjects with eosinophilic esophagitis Subjects with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease .

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP14012 A mg<br>DWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks | Drug: DWP14012 A mg<br>* 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.<br>|
| Experimental: DWP14012 B mg<br>DWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks | Drug: DWP14012 B mg<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo, tablet, once daily, oral administration for up to 4 weeks | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. 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) | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux disease symptom assessment using RDQ(Reflux disease questionnaire) |  | 2 week, 4 week | 
| Reflux disease symptom assessment using Subject diary |  | 4 week | 
| Quality of Life assessment using PAGI-QoL |  | 4 week | 
| Use of rescue medication |  | 4 week |