Barrett's Esophagus - 315 - 3 Way Cross Over

January 20, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Nexium 40mg
Drug: Esomeprazole
40mg twice daily
Other Names:
  • Nexium
Experimental: 2
Nexium 40mg + aspirin
Drug: Aspirin
Drug: Esomeprazole
40mg twice daily
Other Names:
  • Nexium
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period.
Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period
Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 316
  • D9612L00057 (Other Identifier: AZ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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