Barrett's Esophagus - 315 - 3 Way Cross Over

Barrett's Esophagus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637988
• Other study ID #: 316
• Secondary ID: D9612L00057
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2008
• Last updated: January 20, 2011
• Start date: April 2002
• Est. completion date: June 2003

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Drug:
• Esomeprazole
40mg twice daily
• Aspirin

• Rofecoxib
25mg once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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