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OpenTrials
Completed

NCT Number: NCT00637988

Barrett's Esophagus - 315 - 3 Way Cross Over

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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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole

Drug

40mg twice daily

Other names: Nexium

Aspirin

Drug

Rofecoxib

Drug

25mg once daily

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 18, 2008
Registry last updated
Jan 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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