Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the efficacy of CJ-12420, once daily (QD), compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8

Detailed Description
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This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 100 mg or esomeprazole 40 mg). All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daytime and nighttime symptom in a subject diary on a daily basis.

Official Title
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A Double-blind, Randomized, Active-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Conditions
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Erosive Esophagitis

Intervention / Treatment
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* Drug: CJ-12420 100 mg QD
* Drug: Esomeprazole 40 mg QD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged between 20 and 70 years Subjects who had experienced heartburn and regurgitation within 7 days before visit 1. Entry into study also required that patients had experienced at least mild upper gastrointestinal symptoms on at least 2 days/week or at least moderate upper gastrointestinal symptoms on at least 1 day/week Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study Subjects who voluntarily signed written informed consent form Subjects who agreed to use medically acceptable contraceptives during the period of study. Exclusion Criteria: Subjects who cannot undergo EGD Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool Subjects with eosinophilic esophagitis Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery Pregnant or lactating women Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc. Subjects who participated in the other clinical trial within 4 weeks prior to randomization

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: CJ-12420 100 mg QD<br>CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks | Drug: CJ-12420 100 mg QD<br>* CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100 mg.<br>* Other names: Not yet decided;|
| Active Comparator: Esomeprazole 40 mg QD<br>Esomeprazole 40 mg, tablet, once daily, oral administration for up to 8 weeks | Drug: Esomeprazole 40 mg QD<br>* Esomeprazole 40 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40 mg.<br>* Other names: Nexium;|

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 8-week |  | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing rate of erosive esophagitis at 4-week |  | 4 week | 
| Symptom assessment by subject diary and questionnaire |  | 4 week or 8 week |