Barrett's Esophagus - 315 - 3 Way Cross Over

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00637988

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Drug: Esomeprazole Drug: Aspirin Drug: Rofecoxib	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Jun 1, 2003

Actual Study Completion Date :

Jun 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Nexium 40mg	Drug: Esomeprazole 40mg twice daily Other Names: Nexium
Experimental: 2 Nexium 40mg + aspirin	Drug: Esomeprazole 40mg twice daily Other Names: Nexium Drug: Aspirin
Experimental: 3 Nexium 40mg + Rofecoxib 25 mg	Drug: Esomeprazole 40mg twice daily Other Names: Nexium
Active Comparator: 4 Rofecoxib 25mg	Drug: Rofecoxib 25mg once daily

Outcome Measures

Primary Outcome Measures

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 [Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period.]

Secondary Outcome Measures

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. [Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.