GoutPhase 4CONTACTNCT01994226
Colchicine Or Naproxen Treatment for ACute gouT
A Phase 4 study testing Low-dose colchicine and Naproxen 750 mg/250 mg in people with Gout, run by Keele University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- What is being tested?
- Low-dose colchicine and Naproxen 750 mg/250 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Mar 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gout
- Being tested
- Low-dose colchicine, Naproxen 750 mg/250 mg
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose colchicineDrug
Also called Colchicine 500 mcg
Route of Administration: Tablet - Oral Use
Dose: 500 mcg (one tablet) every eight hours for four days
Naproxen 750 mg/250 mgDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Low-dose colchicine | Active comparator | 500 mcg every eight hours for four days Receives: Drug: Low-dose colchicine |
| Naproxen | Active comparator | Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days Receives: Drug: Naproxen 750 mg/250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Worst pain intensity in last 24 hours using a 0 - 10 numeric rating scale, where high rates (10) indicate worst outcome
Measured: Days 0-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ed Roddy, Study chair, Cheif Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994226
- Sponsor's protocol ID
- 149/11
- Acronym
- CONTACT
- Status last verified
- Jun 2019
- First submitted
- 19 Nov 2013
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McKenzie BJ, Wechalekar MD, Johnston RV, Schlesinger N, Buchbinder R. Colchicine for acute gout. Cochrane Database Syst Rev. 2021 Aug 26;8(8):CD006190. doi: 10.1002/14651858.CD006190.pub3.
PubMed 34438469Roddy E, Clarkson K, Blagojevic-Bucknall M, Mehta R, Oppong R, Avery A, Hay EM, Heneghan C, Hartshorne L, Hooper J, Hughes G, Jowett S, Lewis M, Little P, McCartney K, Mahtani KR, Nunan D, Santer M, Williams S, Mallen CD. Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care. Ann Rheum Dis. 2020 Feb;79(2):276-284. doi: 10.1136/annrheumdis-2019-216154. Epub 2019 Oct 30.
PubMed 31666237
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Open-label, Active-comparator, Pragmatic Clinical Trial of Low-dose Colchicine Versus Naproxen in Patients With Acute Gout.
- ClinicalTrials.gov ID
- NCT01994226
- Acronym / sponsor ID
- CONTACT / 149/11
- Conditions
- Gout
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 5 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose colchicine | Active comparator | Drug: Low-dose colchicine500 mcg every eight hours for four days |
| Naproxen | Active comparator | Drug: Naproxen 750 mg/250 mgSingle initial dose of 750 mg followed by 250 mg every eight hours for up to seven days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose colchicineAlso: Colchicine 500 mcgRoute of Administration: Tablet - Oral Use Dose: 500 mcg (one tablet) every eight hours for four days | Drug | Low-dose colchicine |
| Naproxen 750 mg/250 mgRoute 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 | Drug | Naproxen |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34438469McKenzie BJ, Wechalekar MD, Johnston RV, Schlesinger N, Buchbinder R. Colchicine for acute gout. Cochrane Database Syst Rev. 2021 Aug 26;8(8):CD006190. doi: 10.1002/14651858.CD006190.pub3.
- Derived from this study: PubMed 31666237Roddy E, Clarkson K, Blagojevic-Bucknall M, Mehta R, Oppong R, Avery A, Hay EM, Heneghan C, Hartshorne L, Hooper J, Hughes G, Jowett S, Lewis M, Little P, McCartney K, Mahtani KR, Nunan D, Santer M, Williams S, Mallen CD. Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care. Ann Rheum Dis. 2020 Feb;79(2):276-284. doi: 10.1136/annrheumdis-2019-216154. Epub 2019 Oct 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed Roddy study chair
Cheif Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-dose colchicine and Naproxen 750 mg/250 mg in people with Gout, run by Keele University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Days 0-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01994226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.