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A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia

NCT00357682 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2557

Last updated 2025-05-01

Study results available
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Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of esomeprazole and aspirin may prevent esophageal cancer in patients with Barrett's metaplasia. It is not yet known whether esomeprazole is more effective with or without aspirin in preventing esophageal cancer in patients with Barrett's metaplasia.

PURPOSE: This randomized phase III trial is studying esomeprazole with or without aspirin to compare how well they work in preventing esophageal cancer in patients with Barrett's metaplasia.

Conditions

  • Esophageal Cancer
  • Precancerous Condition

Interventions

DRUG

Esomeprazole

20mg per day

DRUG

Esomeprazole

80mg per day

DRUG

Aspirin

300mg per day

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Janusz Jankowski, MD · National Institute for Health and Care Excellence

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-10
Primary Completion
2017-05-31
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00357682 on ClinicalTrials.gov