|Funder name / reference number:
|NIHR School for Primary Care Research
|UKCRN Study portfolio:
|Clinical trials ID: NCT01994226, ID Ref:149/11
Gout is the most prevalent inflammatory arthritis and is largely managed within primary care but treatment is often suboptimal. Acute gout causes attacks of excruciating joint pain and requires rapid treatment. In primary care, treatment is most frequently with non-steroidal anti-inflammatory drugs (NAIDs), which are effective but have frequent gastrointestinal, cardiovascular and renal side-effects, particularly in the elderly. 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 is a randomised controlled trial which compared the effectiveness of low-dose colchicine and naproxen for reducing pain in adults aged 18 years and over consulting their GP with acute gout.
This pragmatic randomised trial compares 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 are eligible to participate.
All patients registered with each participating practice have consulted with gout in the preceding two years is 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.
Outcome measures are collected via self-complete questionnaires at day 1-7 (daily diary), and 4 weeks.
To compare the effectiveness, safety, and cost-effectiveness of low-dose colchicine and Naproxen (a non-steroidal anti-inflammatory drug) in the treatment of acute gout in primary care, using a randomised, multi-centre pragmatic clinical trial.
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.
The primary outcome measure is the 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.
Download the study protocol