Colchicine Or Naproxen Treatment for ACute gouT

Gout is the most prevalent inflammatory arthritis. It is largely managed in primary care but treatment is often suboptimal. Acute gout causes attacks of excruciating joint pain requiring rapid treatment. In primary care, treatment is most frequently with non-steroidal anti-inflammatory drugs (NSAIDs) which are effective but have frequent gastrointestinal, cardiovascular and renal side-effects, particularly in the elderly. Oral colchicine has been used to treat acute gout for many years although high-doses can cause intolerable gastrointestinal side-effects. Low-dose colchicine is thought to be as effective and better-tolerated and is now recommended by the British National Formulary. However, there has been no direct comparison of NSAID and low-dose colchicine for acute gout.

This pragmatic randomised trial will compare the effectiveness of low-dose colchicine (500 mcg three times every eight hours) and naproxen (750 mg immediately followed by 250 mg every eight hours) for reducing pain in adults aged 18 years and over consulting their GP with acute gout, recruited from up to 100 general practices. People experiencing their first attack of gout or a recurrent attack will be eligible to participate. However, all patients registered with each participating practice who have consulted with gout in the preceding two years will be mailed a letter of invitation and Participant Information Sheet informing them that the trial is taking place and encouraging them to consult their GP if they experience an attack of acute gout. Eligibility assessment, informed consent, randomisation, baseline data collection and prescription will be performed when the patient consults in primary care with acute gout. Outcome measures will be collected via self-complete questionnaires at days 1-7 (daily diary), and 4 weeks. The primary outcome measure will be change in worst pain intensity in the previous 24 hours measured daily over days 0-7. Secondary outcome measures include side-effects, time to treatment response, patient global assessment of response to treatment, adherence to treatment, use of other medications for pain relief, and cost. A sample size of 200 patients per treatment arm provides 90% power to detect a minimum clinically important treatment effect of a small standardised effect size of 0.3 between the treatment groups.

Inclusion criteria

• Adults aged 18 years and over
• Consultation with GP, primary care out-of-hours service or walk-in-centre
• Current attack of acute gout (first attack or recurrent).
• Patient has capacity and willingness to give consent and complete the trial paperwork

Exclusion criteria

• Known unstable medical conditions (such as ischaemic heart disease, impaired liver function)
• Known stage 4/5 kidney disease (eGFR/creatinine clearance <30ml/min)
• Recent surgery or gastrointestinal bleed
• History of gastric ulcer
• Current anticoagulant use
• Allergy to aspirin/NSAID
• Previous inability to tolerate naproxen or low-dose colchicine
• Other contraindication to either study drug in accordance with the Summary of Product Characteristics (SPC)
• Prescription of naproxen or colchicine in the previous 24 hours
• Pregnant or lactating females
• Potentially vulnerable
• Previous participation in the CONTACT trial during a previous acute attack of gout.
• Involvement in another clinical trial of an investigational medicinal product in the last 90 days or any other research within the last 30 days