Phase 3 Completed N=2,557 Randomized Prevention

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

Esophageal Cancer · Precancerous Condition

Source: ClinicalTrials.gov NCT00357682 ↗

Enrolled (actual)

2,557

Serious AEs

29.8%

Results posted

May 2025

Primary outcomePrimary: First Event of Death, Oesophageal Adenocarcinoma, High Grade Dysplasia — 127; 154; 174; 139 Participants — p=0.068

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY First Event of Death, Oesophageal Adenocarcinoma, High Grade Dysplasia	127; 154; 174; 139	0.068
SECONDARY All Cause Mortality	73; 90; 105; 79	0.039 sig
SECONDARY Adenocarcinoma Oesophageal Cancer	35; 35; 41; 40	0.864
SECONDARY High Grade Dysplasia	37; 55; 59; 44	0.119

Eligibility Criteria

INCLUSION CRITERIA

Aged ≥18 years.
Circumferential Barrett's metaplasia of at least 1cm in length (≥C1M1) or a tongue of Barrett's metaplasia of at least 2cm in length (≥C0M2) (irrespective of the presence now or historically of histologically proven intestinal metaplasia).
Able to give written informed consent.
WHO performance status of 0 or 1 i.e. fully active and self-caring.

EXCLUSION CRITERIA

High grade dysplasia or carcinoma at enrolment.
Medical conditions which would make completing endoscopies or completing the trial difficult including:
Frequent transient ischaemic attacks (3 or more) or severe cerebral vascular accident in the previous 6 months*
Severe respiratory disease with arterial oxygen saturation less 90% at rest
Severe ischaemic heart disease (exercise tolerance less than 100 yards or life expectancy 6 times/day * Patients answering yes to criterion a. were eligible for the PPI-only (non-aspirin) arms of the trial
Continuous/frequent non-steroidal anti-inflammatory drug use or COX-2 inhibitors (more than 60 days per year in total).
Patients with absolute contraindications to PPIs, aspirin or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants.
Pregnant or lactating women will not undergo endoscopy and may be given dispensation to stop drug therapy for a year. This should be discussed with the Trial Office.

If a patient was suitable for inclusion but later becomes unsuitable this should be discussed with the Trial Office before they are withdrawn. Only in exceptional circumstances should patients not be followed up i.e. withdrawal of consent or current life threatening disease with poor outcome and therefore unable to tolerate endoscopy. In these circumstances patients should be followed up in outpatient clinics.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00357682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.