CONTACT v1.0
Research type
Research Study
Full title
A randomised, multi-centre, open-label, active-comparator, pragmatic clinical trial of low-dose colchicine versus naproxen in patients with acute gout.
IRAS ID
123700
Contact name
Edward Roddy
Contact email
Sponsor organisation
Keele University
Eudract number
2013-001354-95
ISRCTN Number
0
Clinicaltrials.gov Identifier
0
Research summary
Gout is the most common cause of inflamed joints affecting 1.4% of adults in the UK. Most patients are treated entirely in general practice yet primary care management is frequently suboptimal. Acute attacks of gout are excruciatingly painful and require urgent drug treatment to reduce inflammation, most commonly with anti-inflammatory drugs (NSAIDs) or colchicine. In primary care, NSAIDs are most commonly used but can cause serious side-effects such as stomach ulcers and heart disease, particularly in the elderly. Patients frequently require repeat prescriptions for recurrent attacks of acute gout increasing the risk of drug-related side-effects. Low-dose colchicine is popular amongst rheumatologists as it is effective and well-tolerated. However, general practitioners (GPs) prescribe colchicine infrequently, probably because in the past the recommendation was for high doses to be prescribed which commonly caused severe diarrhoea. Recently, prescribing recommendations for colchicine have changed, advocating a lower-dose regime.
Currently there is no evidence regarding whether NSAIDs or low-dose colchicine is the best treatment for acute gout. This trial will be the first direct comparison of the effectiveness and side-effects of a NSAID (naproxen) and low-dose colchicine to treat acute gout in primary care. Naproxen will be used in this trial because it has been shown to be as effective as oral prednisolone for the treatment of acute gout, is safer than other commonly used NSAIDs such as diclofenac and indomethacin, and is inexpensive.
Patients consulting their GP with an acute attack of gout in up to 100 general practices will be invited to participate. Treatment success will be assessed by comparing pain reduction between the two drugs. The trial will also monitor side-effects, quality of life, and cost effectiveness.
REC name
North West - Haydock Research Ethics Committee
REC reference
13/NW/0353
Date of REC Opinion
13 Jun 2013
REC opinion
Further Information Favourable Opinion