Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
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 it is frequently not enough. Acute attacks of gout are excruciatingly painful and require urgent drug treatment to reduce inflammation, most commonly with non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine. In GP surgeries, 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) seldom prescribe colchicine, 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 study is the first direct comparison of the effectiveness and side-effects of a NSAID (naproxen) and low-dose colchicine to treat acute gout in GP surgeries.

Who can participate?
Patients aged 18 and over consulting their GP, in participating GP practices, with an acute attack of gout

What does the study involve?
Participants are randomly allocated to receive either low-dose colchicine or Naproxen. Treatment success is assessed by comparing pain reduction between the two drugs using follow-up questionnaires. The study also monitors side-effects, quality of life and cost effectiveness.

What are the possible benefits and risks of participating?
Although there is no expected direct benefit for the patient, it is hoped that the study will improve the understanding of how to treat patients with gout in the future. The study is considered to pose no additional risks to participants than normal care for gout.

Where is the study run from?
The study is run from up to 100 general practices across England.

When is the study starting and how long is it expected to run for?
January 2014 to March 2016

Who is funding the study?
National Institute for Health Research (NIHR) School for Primary Care Research (UK)

Who is the main contact?
Ms Jacqueline Gray

Trial website

Contact information



Primary contact

Ms Jacqueline Gray


Contact details

Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
United Kingdom



Additional contact

Dr Clark Crawford


Contact details

Keele University
United Kingdom

Additional identifiers

EudraCT number

2013-001354-95 number


Protocol/serial number


Study information

Scientific title

Colchicine Or Naproxen Treatment for ACute gouT: a randomised controlled trial



Study hypothesis

A randomised, multi-centre, open-label, active-comparator, pragmatic clinical trial of low-dose colchicine versus naproxen in patients with acute gout.

Ethics approval

NRES Committee North West - Haydock, 13/06/2013, ref: 13/NW/0353

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases


Participants will be randomised on a 1:1 basis to low-dose colchicine (500 mcg orally every eight hours for four days) or Naproxen (Single initial dose of 750 mg followed by 250 mg orally every eight hours for up to seven days). Participants will be followed up for 4 weeks.

Intervention type



Phase IV

Drug names

Colchicine, Naproxen

Primary outcome measure

Pain intensity, measured on a 0-10 pain intensity numeric rating scale over days 0-7

Secondary outcome measures

1. Adherence to trial treatment, measured using patient self report; Timepoint(s): days 1-7
2. Quality of life, measured using EQ-5D 5-L; Timepoint(s): day 7 and 4 weeks
3. Healthcare utilisation (re-attendance at GP/accident and emergency/primary care out-of-hours service), measured using patient self report; Timepoint(s): 4 weeks
4. Patient global assessment of response to treatment, measured using patient self report; Timepoint(s): day 7 and 4 weeks
5. Relapse/recurrence of acute gout, measured using patient self report; Timepoint(s): 4 weeks
6. Side-effects (e.g. nausea, vomiting, dyspepsia, diarrhoea and abdominal pain), measured using a self-reported questionnaire; Timepoint(s): days 1-7, 4 weeks
7. Time off work/education, measured using patient self report; Timepoint(s): 4 weeks
8. Use of other medications for pain relief (e.g. steroids, paracetamol, opiates), measured using patient self report; Timepoint(s): days 1 - 7 and 4 weeks

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Adults aged 18 years and over
2. Current attack of acute gout (first attack or recurrent)
3. Capacity and willingness to give consent and complete the trial paperwork
Target Gender: Male & Female; Lower Age Limit 18 years

Participant type


Age group




Target number of participants

Planned Sample Size: 400; UK Sample Size: 400

Total final enrolment


Participant exclusion criteria

1. Known unstable medical conditions (such as ischaemic heart disease, impaired liver function)
2. Known stage 4/5 kidney disease
3. Recent surgery or gastrointestinal bleed
4. History of gastric ulcer
5. Current anticoagulant use
6. Allergy to aspirin/nonsteroidal anti-inflammatory drugs (NSAID)
7. Previous inability to tolerate naproxen or low-dose colchicine
8. Other contraindication to either study drug in accordance with the Summary of Product Characteristics (SPC)
9. Prescription of naproxen or colchicine in the previous 24 hours
10. Pregnant or lactating females
11. Potentially vulnerable
12. Previous participation in the CONTACT trial during a previous acute attack of gout
13. Involvement in another clinical trial of an investigational medicinal product in the last 90 days or any other research within the last 30 days

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Keele University
United Kingdom

Trial participating centre

100 GP sites
United Kingdom

Sponsor information


University of Keele (UK)

Sponsor details

United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research - School for Primary Care Research (UK)

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

Abstracts have been accepted for oral presentation at the NIHR School for Primary Care Research Showcase November 2016 and British Society for Rheumatology annual conference April 2017. A single paper is planned reporting both the clinical and cost effectiveness outcomes in a high impact journal.

IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

See additional file ISRCTN69836939_BasicResults_28Apr2017.pdf
See ( (added 09/08/2019)
See ( (added 09/08/2019)

Publication list

2019 results in (added 04/11/2019)

Publication citations

Additional files

Editorial Notes

04/11/2019: Publication reference added. 09/08/2019: The following changes were made to the trial record: 1. number added. 2. Proactive update review. Added link to basic results (scientific). Added total final enrollment. 3. Added link to basic results (scientific). Added total final enrollment. 4. The trial website was added. 05/05/2017: The basic results of this trial have been uploaded as an additional file. 23/07/2015: The overall trial end date was changed from 25/05/2015 to 31/03/2016.