Reflux Esophagitis Phase III Study (Initial Treatment)

Study Overview
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Brief Summary
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This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .

Official Title
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A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis

Conditions
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Reflux Esophagitis

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Esomeprazole
* Drug: Omeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation Exclusion Criteria: Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation. Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.

Ages Eligible for Study
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Minimum Age: 20 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: 1<br>Esomeprazole 20mg | Drug: Esomeprazole<br>* 20mg once daily<br>* Other names: Nexium;|
| Experimental: 2<br>Esomeprazole 40mg | Drug: Esomeprazole<br>* 40 mg once daily<br>* Other names: Nexium;|
| Active Comparator: 3<br>Omeprazole 20mg | Drug: Omeprazole<br>* 20mg once daily<br>* Other names: Prilosec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification. | Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification | Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reflux Esophagitis