Colchicine Or Naproxen Treatment for ACute gouT (CONTACT)

June 6, 2019 updated by: Keele University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gout is the most prevalent inflammatory arthritis. It is largely managed in primary care but treatment is often suboptimal. Acute gout causes attacks of excruciating joint pain requiring rapid treatment. In primary care, treatment is most frequently with non-steroidal anti-inflammatory drugs (NSAIDs) which are effective but have frequent gastrointestinal, cardiovascular and renal side-effects, particularly in the elderly. Oral colchicine has been used to treat acute gout for many years although high-doses can cause intolerable gastrointestinal side-effects. 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 pragmatic randomised trial will compare 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 will be eligible to participate. However, all patients registered with each participating practice who have consulted with gout in the preceding two years will be 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. Eligibility assessment, informed consent, randomisation, baseline data collection and prescription will be performed when the patient consults in primary care with acute gout. Outcome measures will be collected via self-complete questionnaires at days 1-7 (daily diary), and 4 weeks. The primary outcome measure will be 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. A sample size of 200 patients per treatment arm provides 90% power to detect a minimum clinically important treatment effect of a small standardised effect size of 0.3 between the treatment groups.

Study Type

Interventional

Enrollment (Actual)

399

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low-dose colchicine
500 mcg every eight hours for four days
Drug: Low-dose colchicine

Route of Administration: Tablet - Oral Use

Dose: 500 mcg (one tablet) every eight hours for four days

Other Names:
  • Colchicine 500 mcg
Active Comparator: Naproxen
Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days
Drug: Naproxen 750 mg/250 mg

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity
Time Frame: Days 0-7
Worst pain intensity in last 24 hours using a 0 - 10 numeric rating scale, where high rates (10) indicate worst outcome
Days 0-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keele University

Investigators

  • Study Chair: Ed Roddy, Cheif Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 149/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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