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Barrett's Esophagus - 315 - 3 Way Cross Over

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 11, 2008
Last updated: January 20, 2011
Last verified: January 2011
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00637988

Sponsors and Collaborators
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
  More Information

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca Identifier: NCT00637988     History of Changes
Other Study ID Numbers: 316
D9612L00057 ( Other Identifier: AZ )
Study First Received: March 11, 2008
Last Updated: January 20, 2011

Keywords provided by AstraZeneca:
Barrett's Esophagus

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Cyclooxygenase 2 Inhibitors processed this record on May 25, 2017