Acute Gout MedDRA version: 16.0 Level: PT Classification code 10018627 Term: Gout System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Colchicine
Pharmaceutical Form: Tablet
INN or Proposed INN: Colchicine
CAS Number: 64-86-8
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: µg microgram(s)
Concent
Sponsors
Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults aged 18 years and over • Consultation with their GP, primary care out-of-hours service or walk-in-centre that is approved for the trial. • Current attack of acute gout (first attack or recurrent). The diagnosis of gout will be made on clinical grounds and will not require joint aspiration, blood tests, imaging or clinical criteria. • Patient has capacity and willingness, in the view of the recruiting clinician, to give consent and complete the trial paperwork, including the symptom diary. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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 of 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) supplied in the Investigator Site File • Prescription of naproxen or colchicine in the previous 24 hours • Pregnant or lactating females • Potentially vulnerable individuals • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research objective is to compare the effectiveness of two licensed drugs, which are frequently prescribed within primary care, to reduce pain from acute gout; namely low-dose colchicine and naproxen. ;Secondary Objective: The secondary research objectives are: • To compare the side-effects of two drugs (namely low-dose colchicine and naproxen), which are commonly prescribed to treat acute gout in primary care. • To compare the cost-effectiveness of low-dose colchicine and naproxen for the treatment of acute gout in primary care • To compare whether patients take each drug as prescribed • To compare the time taken for low-dose colchicine and naproxen to reduce pain in patients with acute gout. ;Primary end point(s): The primary outcome measure is the change in a 0-10 worst pain intensity numeric rating scale. ;Timepoint(s) of evaluation of this end point: The primary outcome measure will be measured over days 0-7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • the proportion of participants in each group reporting complete resolution of pain and time to treatment effect. • side-effects (nausea, vomiting, dyspepsia, diarrhoea and abdominal pain) via a self-reported drug side-effect questionnaire • patient global assessment of response to treatment • use of other medications for pain relief (for example, steroids, paracetamol, opiates) • adherence to naproxen/low-dose colchicine • relapse/recurrence of acute gout • EQ-5D 5-L, healthcare utilisation (re-attendance at GP/accident and emergency/primary care out-of-hours service), time off work/education ;Timepoint(s) of evaluation of this end point: The secondary endpoints will be measured over 4 weeks. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Studies Coordinator
Keele University
Outcome results
None listed