Barrett's Esophagus - 315 - 3 Way Cross Over

Study Overview
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Brief Summary
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This study evaluates PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue. All patients will have a baseline endoscopy with multiple biopsies. The patients will then be receive four dosing regimens (esomeprazole, esomeprazole and aspirin, esomeprazole and rofecoxib, or rofecoxib alone) consecutively each for a 10 day dosing period, whilst undergoing further follow up endoscopies and multiple biopsies.

Official Title
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A Multicenter, Open-label, Four-way Crossover Study of the Effects of Esomeprazole, Aspirin and Rofecoxib on Prostaglandin (PGE2) Production, Cyclooxygenase-2 Enzyme Activity and PCNA Expression in Patients With Barrett's Esophagus

Conditions
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Barrett's Esophagus

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Aspirin
* Drug: Rofecoxib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A biopsy-proven diagnosis of Barrett's esophagus segment length greater than 2cm with no dysplasia or adenocarcinoma. Clinically normal laboratory results and physical findings at screening. Exclusion Criteria: A history of esophageal, gastric or duodenal surgery, including antireflux surgery or endoscopic antireflux procedures, except for simple closure of an ulcer. Evidence of the following diseases or conditions: Barrett's esophagus less than or greater than 2cm that is positive for high grade dysplasia or adenocarcinoma Signs and symptoms of gastric outlet obstruction Active peptic ulcer disease severe liver disease Pancreatitis Malabsorption Active inflammatory bowel disease Severe pulmonary, cardiovascular or renal disease Impaired renal function or abnormal urine sediment on repeated examinations esophageal stricture or active, severe esophagitis.

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nexium 40mg | Drug: Esomeprazole<br>* 40mg twice daily<br>* Other names: Nexium;|
| Experimental: 2<br>Nexium 40mg + aspirin | Drug: Esomeprazole<br>* 40mg twice daily<br>* Other names: Nexium;Drug: Aspirin<br> <br> |
| Experimental: 3<br>Nexium 40mg + Rofecoxib 25 mg | Drug: Esomeprazole<br>* 40mg twice daily<br>* Other names: Nexium;|
| Active Comparator: 4<br>Rofecoxib 25mg | Drug: Rofecoxib<br>* 25mg once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure PGE production in Barrett's metastatic tissue & determine the reduction from baseline of PGE production would be equivalent on Day 10 in esomeprazole 40mg bid + aspirin treatment compared to esomeprazole 40 mg bid + rofecoxib 25 mg qd treatment |  | Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine in which of the four treatment groups the reduction in the baseline in PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue is the greatest. |  | Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's Esophagus, Nexium