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

You may not qualify if:

• 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 \< 4 years) or myocardial infarction in the previous 3 months
• Severe inflammatory bowel disease requiring at least one hospital admission of 5 days in the last year or bowels open \> 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.