Trials / Completed
CompletedNCT00637988
Barrett's Esophagus - 315 - 3 Way Cross Over
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 Patients With Barrett's Esophagus
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esomeprazole | 40mg twice daily |
| DRUG | Aspirin | |
| DRUG | Rofecoxib | 25mg once daily |
Timeline
- Start date
- 2002-04-01
- Primary completion
- 2003-06-01
- Completion
- 2003-06-01
- First posted
- 2008-03-18
- Last updated
- 2011-01-21
Source: ClinicalTrials.gov record NCT00637988. Inclusion in this directory is not an endorsement.