Colchicine Or Naproxen Treatment for ACute gouT

NCT01994226 | Completed Phase 4 Results DMC

• 1 other identifier: 149/11
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• 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

  Days 0-7

Study Arms (2)

Low-dose colchicine

ACTIVE COMPARATOR

500 mcg every eight hours for four days

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

Drug: Naproxen 750 mg/250 mg

Interventions

Low-dose colchicine DRUG

Route of Administration: Tablet - Oral Use Dose: 500 mcg (one tablet) every eight hours for four days

Also known as: Colchicine 500 mcg

Low-dose colchicine

Naproxen 750 mg/250 mg DRUG

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

Naproxen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Keele University: lead

Study Sites (1)

Keele University

Stoke-on-Trent, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34438469 DERIVED

• Roddy 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.

  PMID: 31666237 DERIVED

MeSH Terms

Conditions

Gout

Interventions

Colchicine; Naproxen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Sponsor
• Organization: Keele University

research.governance@keele.ac.uk

01782

Study Officials

• Ed Roddy

  Cheif Investigator

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 18, 2019
• Results First Posted: February 5, 2018

Record last verified: 2019-06

Locations

GB (1)