Study identifier:316
ClinicalTrials.gov identifier:NCT00637988
EudraCT identifier:N/A
CTIS identifier:N/A
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
Barrett's esophagus
Phase 4
No
Esomeprazole, Aspirin, Rofecoxib
All
32
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 Nexium 40mg | Drug: Esomeprazole 40mg twice daily Other Name: Nexium |
Experimental: 2 Nexium 40mg + aspirin | Drug: Esomeprazole 40mg twice daily Other Name: Nexium |
Experimental: 3 Nexium 40mg + Rofecoxib 25 mg | Drug: Esomeprazole 40mg twice daily Other Name: Nexium |
Active Comparator: 4 Rofecoxib 25mg | Drug: Rofecoxib 25mg once daily |
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