Barrett's Esophagus
Conditions
Keywords
Barrett's Esophagus, Nexium
Brief summary
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.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed