A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients

Study Overview
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Brief Summary
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To evaluate the healing rate and safety of Lafutidine in erosive esophagitis

Official Title
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A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Koran Erosive Esophagitis Patients

Conditions
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Erosive Esophagitis

Intervention / Treatment
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* Drug: Lafutidine
* Drug: Famotidine
* Drug: Omeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification Exclusion Criteria: Gastric or duodenal ulcers (excluding ulcer scars) Concurrent presence of Barrett's esophagus A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety

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: Lafutidine<br>Lafutidine 20mg/day | Drug: Lafutidine<br>* Lafutidine 20mg/day<br>|
| Active Comparator: Famotidine<br>Famotidine 40mg/day | Drug: Famotidine<br>* Famotidine 40mg/day<br>|
| Other: Omeprazole<br>Omeprazole 20mg/day | Drug: Omeprazole<br>* Omeprazole 20mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Rates of Reflux Esophagitis | Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Days Without 'Cardinal Symptom' | The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain | 4 or 8 week | 
| The Proportion of Daytimes Without 'Cardinal Symptom' | The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain | 4 or 8 week | 
| The Proportion of Nighttimes Without 'Cardinal Symptom' | The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain | 4 or 8 week |