Barrett's Esophagus - 315 - 3 Way Cross Over

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Barrett's Esophagus

Treatments: Drug: Esomeprazole; Drug: Aspirin; Drug: Rofecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637988

316

D9612L00057 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

1

Experimental group

Description:

Nexium 40mg

Treatment:

Drug: Esomeprazole

2

Experimental group

Description:

Nexium 40mg + aspirin

Treatment:

Drug: Esomeprazole

Drug: Aspirin

3

Experimental group

Description:

Nexium 40mg + Rofecoxib 25 mg

Treatment:

Drug: Esomeprazole

4

Active Comparator group

Description:

Rofecoxib 25mg

Treatment:

Drug: Rofecoxib