Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed

Study Overview
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Brief Summary
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A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).

Official Title
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Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed.

Conditions
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Erosive Esophagitis

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Lansoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Episodes of heartburn (described as a burning feeling rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline Confirmed diagnosis of Erosive Esophagus, patients must undergo an endoscopy before entering the study. Exclusion Criteria: Any signs of gastrointestinal bleeding at the time of the starting the study. Any previous gastric or esophageal surgery. Various gastrointestinal diseases as listed in the protocol.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nexium | Drug: Esomeprazole<br> <br> * Other names: Nexium;|
| Active Comparator: 2<br>Prevacid | Drug: Lansoprazole<br> <br> * Other names: Prevacid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE). |  | Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE. |  | Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6 | 
| The assessment of symptoms in the two treatment groups after 1, 3 and 6 months. |  | patients will undergo an endoscopy at Months 3 and 6 | 
| To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE. |  | Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erosive Esophagitis, Nexium, Esomeprazole, Lansoprazole, Heartburn