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Gout | Colchicine Or Naproxen Treatment for ACute gouT

Gout research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Gout

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Low-dose colchicineRoute of Administration: Tablet - Oral Use Dose: 500 mcg (one tablet) every eight hours for four days

Drug:Naproxen 750 mg/250 mgRoute 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Low-dose colchicine500 mcg every eight hours for four days

NaproxenSingle initial dose of 750 mg followed by 250 mg every eight hours for up to seven days

Study Status

Completed

Start Date: January 2014

Completed Date: March 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change in pain intensity

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Ed Roddy

Lead Sponsor: Keele University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01994226

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