Condition category
Musculoskeletal Diseases
Date applied
21/11/2013
Date assigned
21/11/2013
Last edited
25/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 and will run for 12-18 months.

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
j.gray@keele.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jacqueline Gray

ORCID ID

Contact details

Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
-
j.gray@keele.ac.uk

Type

Scientific

Additional contact

Dr Clark Crawford

ORCID ID

Contact details

Keele University
Keele
ST5 5BG
United Kingdom
-
research.governance@keele.ac.uk

Additional identifiers

EudraCT number

2013-001354-95

ClinicalTrials.gov number

Protocol/serial number

15555

Study information

Scientific title

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

Acronym

CONTACT

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

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

Intervention

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

Drug

Phase

Phase IV

Drug names

Colchicine, Naproxen

Primary outcome measures

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

25/11/2013

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 400; UK Sample Size: 400

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

29/01/2014

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

Trial participating centre

100 GP sites
-

Sponsor information

Organisation

University of Keele (UK)

Sponsor details

Keele
Newcastle
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

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

01/12/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/07/2015: The overall trial end date was changed from 25/05/2015 to 31/03/2016.