Colchicine Or Naproxen Treatment for ACute gouT
Condition: Gout
MeSH terms: Gout
Intervention: Low-dose colchicine; Naproxen 750 mg/250 mg
Intervention description: Route of Administration: Tablet - Oral Use
Dose: 500 mcg (one tablet) every eight hours for four days; Route of Administration: Tablet - Oral Use
Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days
Intervention MeSH terms: Naproxen; Colchicine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 399.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 antiinflammatory 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.
    

Eligibility criteria:

        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