Barrett's Esophagus - 315 - 3 Way Cross Over
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Barrett's Esophagus
Intervention: Esomeprazole (Drug); Aspirin (Drug); Rofecoxib (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
Primary outcome: Measure PGE production in Barrett's metastatic tissue & determine the reduction from baseline of PGE production would be equivalent on Day 10 in esomeprazole 40mg bid + aspirin treatment compared to esomeprazole 40 mg bid + rofecoxib 25 mg qd treatment
Secondary outcome: To determine in which of the four treatment groups the reduction in the baseline in PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue is the greatest.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- A biopsy-proven diagnosis of Barrett's esophagus segment length greater than 2cm with
no dysplasia or adenocarcinoma.
- Clinically normal laboratory results and physical findings at screening.
Exclusion Criteria:
- A history of esophageal, gastric or duodenal surgery, including antireflux surgery or
endoscopic antireflux procedures, except for simple closure of an ulcer.
- Evidence of the following diseases or conditions:
- Barrett's esophagus less than or greater than 2cm that is positive for high grade
dysplasia or adenocarcinoma
- Signs and symptoms of gastric outlet obstruction
- Active peptic ulcer disease
- severe liver disease
- Pancreatitis
- Malabsorption
- Active inflammatory bowel disease
- Severe pulmonary, cardiovascular or renal disease
- Impaired renal function or abnormal urine sediment on repeated examinations
- esophageal stricture or active, severe esophagitis.
Locations and Contacts
Additional Information
Starting date: April 2002
Ending date: November 2003
Last updated: March 11, 2008
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