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Colchicine Or Naproxen Treatment for ACute gouT

Information source: Keele University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gout

Intervention: Low-dose colchicine (Drug); Naproxen (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Keele University

Overall contact:
Liz Hartshorne, Phone: 01782 734859, Email: nstccg.keelecontact@nhs.net

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.

Clinical Details

Official title: Multi-centre, Open-label, Active-comparator, Pragmatic Clinical Trial of Low-dose Colchicine Versus Naproxen in Patients With Acute Gout.

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in pain intensity

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Liz Hartshorne, Phone: 01782 734859, Email: nstccg.keelecontact@nhs.net

Additional Information

Starting date: November 2013
Last updated: November 19, 2013

Page last updated: August 23, 2015

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