drugset / Trial / NCT00637988

Barrett's Esophagus - 315 - 3 Way Cross Over

NCT00637988

Phase 4 Completed 32 enrolled AstraZeneca
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2002-04
Primary completion
2003-06
Completion
2003-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule
Subject Esomeprazole Small molecule 40 mg
Comparator rofecoxib Small molecule 25 mg

Indications