Colchicine or naproxen treatment for acute gout
| ISRCTN | ISRCTN69836939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69836939 |
| EudraCT/CTIS number | 2013-001354-95 |
| ClinicalTrials.gov number | NCT01994226 |
| Secondary identifying numbers | 15555 |
- Submission date
- 21/11/2013
- Registration date
- 21/11/2013
- Last edited
- 04/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
j.gray@keele.ac.uk
Contact information
Scientific
Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
| j.gray@keele.ac.uk |
Scientific
Keele University
Keele
ST5 5BG
United Kingdom
| research.governance@keele.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Colchicine Or Naproxen Treatment for ACute gouT: a randomised controlled trial |
| Study 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(s) | NRES Committee North West - Haydock, 13/06/2013, ref: 13/NW/0353 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 25/11/2013 |
| Overall study end date | 31/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 400; UK Sample Size: 400 |
| Total final enrolment | 399 |
| 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 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
- England
- United Kingdom
Study participating centres
ST5 5BG
United Kingdom
United Kingdom
Sponsor information
University/education
Keele
Newcastle
ST5 5BG
England
United Kingdom
"ROR" |
https://ror.org/00340yn33 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 28/04/2017 | 05/05/2017 | No | No | |
| Basic results | 09/08/2019 | No | No | ||
| Basic results | 09/08/2019 | No | No | ||
| Results article | results | 01/02/2020 | 04/11/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN69836939_BasicResults_28Apr2017.pdf
- Uploaded 05/05/2017
Editorial Notes
04/11/2019: Publication reference added.
09/08/2019: The following changes were made to the trial record:
1. ClinicalTrials.gov number added.
2. Proactive update review. Added clinicaltrials.gov link to basic results (scientific). Added total final enrollment.
3. Added clinicaltrialsregister.eu 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.
