Barrett's Esophagus - 315 - 3 Way Cross Over

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Barrett's Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Nexium 40mg

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40mg twice daily

2

Nexium 40mg + aspirin

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40mg twice daily

Aspirin

Intervention Type DRUG

3

Nexium 40mg + Rofecoxib 25 mg

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40mg twice daily

4

Rofecoxib 25mg

Group Type ACTIVE_COMPARATOR

Rofecoxib

Intervention Type DRUG

25mg once daily

Interventions

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Esomeprazole

40mg twice daily

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Rofecoxib

25mg once daily

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No