Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

Study Overview
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Brief Summary
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To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

Detailed Description
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A multicenter, randomized, double-blind, active-controlled phase 4 study to evaluate the efficacy and safety of EsoDuo Tab. 20/800mg in patients with non-erosive reflux disease(NERD)

Official Title
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A Multicenter, Randomized, Double-blind, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg in Patients With Non-erosive Reflux Disease(NERD)

Conditions
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Non-erosive Reflux Disease(NERD)

Intervention / Treatment
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* Drug: EsoDuo Tab. 20/800mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female aged ≥ 19 years Episode of heartburn for 3 months or more during prior to randomization visit. Episode of heartburn for 2 days or more during the last 7 days prior to randomization visit. Grade N, M by EGD test. Exclusion Criteria: Surgery history on stomach or esophagus Active medical history of stomach, esophagus area Other system disorder which can disturb this trial Patients taking the contraindication of concomitant medications Clinically significant Abnormal Lab test Pregnant woman, Breastfeeding woman.

Ages Eligible for Study
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Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EsoDuo Tab. 20/800mg<br>EsoDuo Tab. 20/800mg | Drug: EsoDuo Tab. 20/800mg<br>* Nexium Tab. 20mg<br>|
| Active Comparator: Nexium Tab. 20mg<br>Nexium Tab. 20mg | Drug: EsoDuo Tab. 20/800mg<br>* Nexium Tab. 20mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks. | Compare Experimental group with Active Comparator. | 4 weeks after drug administrations. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks. | Compare Experimental group with Active Comparator. | 2 weeks after drug administrations | 
| Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. | 
| The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. | 
| The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. | 
| The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. | 
| Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. | 
| Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks. | Compare Experimental group with Active Comparator. | 4 weeks after drug administrations. | 
| Time to first resolution of Heartburn(HB), Day 1 | Compare Experimental group with Active Comparator. | 1 day after drug administrations. |