Barrett's Esophagus - 315 - 3 Way Cross Over

Phase 4

Completed

• Conditions: Barrett's Esophagus
• Interventions: Drug: Esomeprazole; Drug: Rofecoxib; Drug: Aspirin

• Registration Number: NCT00637988
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-18
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Esomeprazole	Nexium 40mg
4	Rofecoxib	Rofecoxib 25mg
2	Esomeprazole	Nexium 40mg + aspirin
2	Aspirin	Nexium 40mg + aspirin
3	Esomeprazole	Nexium 40mg + Rofecoxib 25 mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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