Barrett's Esophagus - 315 - 3 Way Cross Over

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Aspirin; Esomeprazole; Rofecoxib

Criteria

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.