Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Randomized, Double-Blind, Active-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease

Conditions
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Erosive Esophagitis

Intervention / Treatment
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* Drug: DWP14012 40mg
* Drug: DWP14012 40mg placebo
* Drug: Esomeprazole 40mg
* Drug: Esomeprazole 40mg placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between 20 and 75 years old based on the date of written agreement Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days Exclusion Criteria: Those who have undergone gastric acid suppression or gastric, esophageal surgery Those who 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 40mg<br>Orally, once daily | Drug: DWP14012 40mg<br>* DWP14012 40mg, tablet, orally, once daily for up to 8 weeks<br>Drug: Esomeprazole 40mg placebo<br>* Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks<br>* Other names: Nexium 40mg placebo;|
| Active Comparator: Esomeprazole 40mg<br>Orally, once daily | Drug: DWP14012 40mg placebo<br>* DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks<br>Drug: Esomeprazole 40mg<br>* Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks<br>* Other names: Nexium 40mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative healing rate of erosive esophagitis at 8week by endoscopy |  | at 8week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative healing rate of erosive esophagitis at 4week by endoscopy |  | at 4week | 
| Reflux disease symptom assessment using RDQ(Reflux disease questionnaire) | Mean change of the frequency or severity of main symptoms | 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 | at 4week and 8week |