Barrett's Esophagus - 315 - 3 Way Cross Over - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00637988

Purpose

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.

Condition	Intervention	Phase
Barrett's Esophagus	Drug: Esomeprazole Drug: Aspirin Drug: Rofecoxib	Phase IV

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

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium Rofecoxib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	32
Study Start Date:	April 2002
Study Completion Date:	June 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Nexium 40mg	Drug: Esomeprazole 40mg twice daily Other Name: Nexium
Experimental: 2 Nexium 40mg + aspirin	Drug: Esomeprazole 40mg twice daily Other Name: Nexium Drug: Aspirin
Experimental: 3 Nexium 40mg + Rofecoxib 25 mg	Drug: Esomeprazole 40mg twice daily Other Name: Nexium
Active Comparator: 4 Rofecoxib 25mg	Drug: Rofecoxib 25mg once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637988

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Responsible Party:	Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca
ClinicalTrials.gov Identifier:	NCT00637988 History of Changes
Other Study ID Numbers:	316, D9612L00057
Study First Received:	March 11, 2008
Last Updated:	January 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Barrett's Esophagus
Nexium

Additional relevant MeSH terms:

Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Aspirin
Rofecoxib
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 12, 2012