NCT00637988

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
Last Updated

January 21, 2011

Status Verified

January 1, 2011

Enrollment Period

1.2 years

First QC Date

March 11, 2008

Last Update Submit

January 20, 2011

Conditions

Barrett's Esophagus

Keywords

Barrett's EsophagusNexium

Outcome Measures

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

    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.

    Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period

Study Arms (4)

1

EXPERIMENTAL

Nexium 40mg

Drug: Esomeprazole

2

EXPERIMENTAL

Nexium 40mg + aspirin

Drug: EsomeprazoleDrug: Aspirin

3

EXPERIMENTAL

Nexium 40mg + Rofecoxib 25 mg

Drug: Esomeprazole

4

ACTIVE COMPARATOR

Rofecoxib 25mg

Drug: Rofecoxib

Interventions

EsomeprazoleDRUG

40mg twice daily

Also known as: Nexium
123
AspirinDRUG
2
RofecoxibDRUG

25mg once daily

4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Barrett Esophagus

Interventions

EsomeprazoleAspirinrofecoxib

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Paula Fernstrom

    Nexium Global Product Director, AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 18, 2008

Study Start

April 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

January 21, 2011

Record last verified: 2011-01