Barrett's Esophagus - 315 - 3 Way Cross Over
Study identifier:316
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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 Patients with Barrett's Esophagus
Medical condition
Barrett's esophagus
Phase
Phase 4
Healthy volunteers
No
Study drug
Esomeprazole, Aspirin, Rofecoxib
Sex
All
Actual Enrollment
32
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Apr 2002
Primary Completion Date: 01 Jun 2003
Study Completion Date: 01 Jun 2003
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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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 |
Contacts
Investigators
Principal Investigator
Paula Fernstrom
Nexium Global Product Director, AstraZeneca
