OCCUR
Research type
Research Study
Full title
A pragmatic randomised trial comparing Oral Corticosteroids and Colchicine for the treatment of goUt flaRes in people with relative contraindications to non-steroidal anti-inflammatory drugs. (OCCUR)
IRAS ID
1011829
Contact name
Mark Lambie
Contact email
Sponsor organisation
Keele University
ISRCTN Number
ISRCTN12564318
Research summary
Background
Gout affects 1 in 40 people in the United Kingdom. It causes flares of severe joint pain and swelling and has a big impact on quality of life. Gout flares are very painful and require urgent drug treatment. They are most often treated with anti-inflammatory painkillers such as ibuprofen (sometimes called nonsteroidal anti-inflammatory drugs or NSAIDs). Many people with gout have other medical problems and can't take NSAIDs. For them, gout flares can be treated with colchicine or steroid tablets. We don’t know whether colchicine or steroid tablets work best for treating gout flares in people who cannot take NSAIDs, and which of these causes fewer side-effects.
Aim
To carry out a clinical trial to find out whether colchicine or steroid tablets provide better pain relief from gout flares in people unable to take NSAIDs, which of these causes fewer side-effects, and which is better value for money for the NHS.
Design and methods
We will complete a trial with 280 adults having a gout flare and who are unable to take NSAIDs. Participants will be recruited from approximately 100 general practices in inner city and rural locations. They will be allocated by chance (randomised) to receive either colchicine or steroid tablets. Participants in both groups will have access to their usual healthcare and will be given a leaflet about gout flares, including information about self-care, rest and ice. Which treatment works best will be assessed by comparing pain between the two groups of participants. We will also ask about how quickly the flare gets better, function, quality of life, side-effects, and cost. All participants will be asked to complete questionnaires at the beginning of the trial and then weekly for 4 weeks. Pain will also be measured twice a day for the first 7 days, then weekly along with the secondary outcomes during weeks 2, 3 and 4.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
25/WM/0121
Date of REC Opinion
18 Jul 2025
REC opinion
Further Information Favourable Opinion