Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care

Research output: Contribution to journalArticlepeer-review


  • Edward Roddy
  • Kris Clarkson
  • Milisa Blagojevic-Bucknall
  • Rajnikant Mehta
  • Anthony Avery
  • Elaine Hay
  • Carl Heneghan
  • Liz Hartshorne
  • Julie Hooper
  • Gemma Hughes
  • Martyn Lewis
  • Paul Little
  • Karen McCartney
  • Kamal Mahtani
  • David Nunan
  • Miriam Santer
  • Sam Williams
  • Christian Mallen

Colleges, School and Institutes

External organisations

  • Keele University
  • Nuffield Department of Primary Care Health Sciences, University of Oxford


Objectives: To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.

Methods: This was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0-10 Numeric Rating Scale) from baseline measured daily over the first 7 days: Mean change from baseline was compared between groups over days 1-7 by intention to treat.

Results: Between 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1-7 (colchicine vs naproxen: Mean difference-0.18; 95% CI-0.53 to 0.17; p=0.32). During days 1-7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54).

Conclusion: We found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications.

Trial registration number: ISRCTN (69836939), (NCT01994226), EudraCT (2013-001354-95).


Original languageEnglish
Pages (from-to)276-284
Number of pages9
JournalAnnals of the Rheumatic Diseases
Issue number2
Early online date30 Oct 2019
Publication statusPublished - Feb 2020


  • Gout, Primary care, Naproxen, Colchicine, Randomised trial