A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis

Study Overview
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Brief Summary
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This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole

Official Title
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A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis.

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 Erosive Esophagitis within 1 week prior to starting 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>* 40mg once daily<br>* Other names: Nexium;|
| Active Comparator: 2<br>Prevacid | Drug: Lansoprazole<br>* 30mg once daily<br>* Other names: Prevacid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale. |  | Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE. |  | Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4) | 
| 1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary. |  | Dairy card to be completed by patient daily | 
| To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE. |  | Adverse event collection on an ongoing basis | 

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