Clinical Trial: Barrett's Esophagus - 315 - 3 Way Cross Over
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Pa
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.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: 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 [ Time Frame: Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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. [ Time Frame: Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period ]
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: March 11, 2008
Date Started: April 2002
Date Completion:
Last Updated: January 20, 2011
Last Verified: January 2011