Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis

Study Overview
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Brief Summary
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This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagitis confirmed on EGD after medication treatment.

Official Title
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A Multi-center, Double-Blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 as Maintenance Therapy in Patients With Healed Erosive Esophagitis

Conditions
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Healed Erosive Esophagitis

Intervention / Treatment
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* Drug: DWP14012 20 mg
* Drug: DWP14012 20 mg placebo
* Drug: Lansoprazole 15 mg
* Drug: Lansoprazole 15 mg Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day) Subjects with healed erosive esophagitis (no mucosal break observed according to LA classification) confirmed on EGD performed within 10 days before Visit 2 (randomization day) after receiving the standard dose of medicinal products of erosive esophagitis (PPI, P-CAB, etc.) for 4 to 8 weeks for the treatment of erosive esophagitis Exclusion Criteria: Subjects who have Barrett's esophagus (> 3 cm), gastroesophageal varix, esophagostenosis, ulcer stenosis, active peptic ulcer, acute gastrointestinal bleeding, or a malignant tumor upon EGD screening Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis. Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system Subjects who have had a malignant tumor in the last 5 years Subjects who must continue to take non-steroidal anti-inflammatory drugs (aspirin, etc.), antithrombotic drugs, etc. during the study period (A low dose of aspirin [100 mg/day] which has been administered for prophylactic purpose before study entry is allowed) Subjects who cannot stop the existing erosive esophagitis treatment being taken

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP14012 20mg<br>Orally, once daily | Drug: DWP14012 20 mg<br>* DWP14012 20 mg, tablet, orally, once daily for up to 24 weeks<br>Drug: Lansoprazole 15 mg Placebo<br>* Lansoprazole 15 mg Placebo capsule, orally, once daily for up to 24 weeks<br>|
| Active Comparator: Lansoprazole 15mg<br>Orally, once daily | Drug: DWP14012 20 mg placebo<br>* DWP14012 20 mg placebo-matching tablet, orally, once daily for up to 24 weeks<br>Drug: Lansoprazole 15 mg<br>* Lansoprazole 15 mg capsule, orally, once daily for up to 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24 |  | at 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12 |  | at 12 week |