Reflux Esophagitis Phase III Study (Maintenance Treatment)

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) 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 Once Daily Oral Administration With Omeprazole 10 mg and Esomeprazole 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed 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: Patients with healed Reflux Esophagitis verified by EGD in the preceding study (D961HC00002) Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI 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 and Omeprazole | Drug: Esomeprazole<br>* 10mg once daily oral administration<br>* Other names: Nexium;Drug: Omeprazole<br>* 10mg once daily oral administration<br>* Other names: Prilosec;|
| Experimental: 2<br>Esomeprazole | Drug: Esomeprazole<br>* 20mg once daily oral administration<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated. | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated. | up to 4 weeks | 
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated. | Up to 12 weeks | 

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