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Barrett's Esophagus - 315 - 3 Way Cross Over

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00637988
First received: March 11, 2008
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  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 4

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:

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 May 22, 2013