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Barrett's Esophagus - 315 - 3 Way Cross Over

NCT00637988 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-01-21

No results posted yet for this study

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

  • Barrett's Esophagus

Interventions

DRUG

Esomeprazole

40mg twice daily

DRUG

Aspirin

DRUG

Rofecoxib

25mg once daily

Sponsors & Collaborators

Principal Investigators

  • Paula Fernstrom · Nexium Global Product Director, AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2003-06-30
Completion
2003-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637988 on ClinicalTrials.gov