Colchicine Or Naproxen Treatment for ACute gouT (CONTACT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Keele University
Sponsor:
Information provided by (Responsible Party):
Keele University
ClinicalTrials.gov Identifier:
NCT01994226
First received: November 19, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Gout
Drug: Low-dose colchicine
Drug: Naproxen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-centre, Open-label, Active-comparator, Pragmatic Clinical Trial of Low-dose Colchicine Versus Naproxen in Patients With Acute Gout.

Resource links provided by NLM:


Further study details as provided by Keele University:

Primary Outcome Measures:
  • Change in pain intensity [ Time Frame: Days 0-7, 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: November 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low-dose colchicine
500 mcg every eight hours for four days
Drug: Low-dose colchicine
Active Comparator: Naproxen
Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days
Drug: Naproxen

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994226

Contacts
Contact: Liz Hartshorne 01782 734859 nstccg.keelecontact@nhs.net

Sponsors and Collaborators
Keele University
  More Information

No publications provided

Responsible Party: Keele University
ClinicalTrials.gov Identifier: NCT01994226     History of Changes
Other Study ID Numbers: 149/11
Study First Received: November 19, 2013
Last Updated: November 19, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Naproxen
Colchicine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 27, 2014