drugset / Trial / NCT00637988
Barrett's Esophagus - 315 - 3 Way Cross Over
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | — | — |
| Subject | Esomeprazole | Small molecule | 40 mg | — |
| Comparator | rofecoxib | Small molecule | 25 mg | — |