Condition category
Musculoskeletal Diseases
Date applied
21/11/2013
Date assigned
21/11/2013
Last edited
23/07/2015
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 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 GP surgeries.

Who can participate?
Patients consulting their GP, in participating GP practices, with an acute attack of gout will be invited to participate.

What does the study involve?
Participants will be randomly allocated to receive either low-dose colchicine or Naproxen Treatment success will be assessed by comparing pain reduction between the two drugs using follow-up questionnaires. The study will also monitor 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 trial will improve the understanding of how to treat patients with gout in the future. The trial 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?
The study will start in January 2014 and will run for 12-18 months.

Who is funding the study?
The study is funded by the 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

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.

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

Ethics approval

13/NW/0353; First MREC approval date 13/06/2013

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 below 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

Change in pain intensity; Timepoint(s): from baseline measured over the first 7 days (1 week)

Secondary outcome measures

1. Adherence to trial treatment; Timepoint(s): Days 1-7
2. EQ-5D 5-L; Timepoint(s): day 7 and 4 weeks
3. Healthcare utilisation; Timepoint(s): 4 weeks
4. Patient global assessment of response to treatment; Timepoint(s): Day 7 and 4 week
5. Relapse/recurrence of acute gout; Timepoint(s): 4 weeks
6. Self-reported side-effects; Timepoint(s): days 1-7, 4 weeks
7. Time off work/education; Timepoint(s): 4 weeks
8. Use of other medications for pain relief; 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

25/11/2013

Recruitment end date

25/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

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

NIHR - School for Primary Care Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes