Treatment Effect According to Timing of Administration of DWP14012 40 mg

Study Overview
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Brief Summary
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The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.

Detailed Description
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Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy. Subjects will visit the site at Week 2 for endoscopic assessment. Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment. Subjects whose mucosal breaks have not healed will continue to receive IPs for an additional 2 weeks and will visit the site for endoscopic assessment at Week 4.

Official Title
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A Multi-Center, Open-label, Randomized Trial to Evaluate the Efficacy and Safety Based on Timing of Administration of DWP14012 in Patients With Erosive Esophagitis

Conditions
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Erosive Esophagitis

Intervention / Treatment
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* Drug: DWP14012
* Drug: DWP14012


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between 19 and 75 years old based on the date of written agreement Those who have been diagnosed with erosive esophagitis 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: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fed state group<br>just after a meal | Drug: DWP14012<br>* DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks<br>* Other names: fed state;|
| Experimental: fasted state group<br>before a meal | Drug: DWP14012<br>* DWP14012 40 mg, orally, once daily before a meal up to 4 weeks<br>* Other names: fasted state;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing rate at 4 week | Cumulative healing rate of erosive esophagitis at 4 week by endoscopy | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing rate at 2 week | Cumulative healing rate of erosive esophagitis at 2 week by endoscopy | 2 week |