AspECT - A phase III, randomised study of aspirin and esomeprazole chemoprevention in Barrett's metaplasia & oesophagitis. - AspECT
- Conditions
- Barrett's Metaplasia
- Registration Number
- EUCTR2004-003836-77-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2535
1. Aged =18 years
2. Circumferential Barrett’s Metaplasia of at least 1cm in length (=C1M1) or a tongue of Barrett’s metaplasia greater than 2cm in length (=C0M2) (with or without histologically proven intestinal metaplasia in at least one sample from this endoscopy or past history of intestinal metaplasia).
3. Able to give written consent
4. WHO performance status of 0 or 1 i.e. fully active and self-caring
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. High grade dysplasia or carcinoma at enrolment
2. Medical conditions which would make completing endoscopies or completing the trial difficult including
a. Previous transient ischaemic attacks or cerebral vascular disease
b. Severe respiratory disease
c. Severe ischaemic heart disease or myocardial infarction in the previous 6 months
d. Inflammatory bowel disease
3. Continuous/frequent non-steroidal anti-inflammatory drug use or COX-2 inhibitors (more than 60 days/year in total)
4. Patients with absolute contraindications to PPIs or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants
5. Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method