Gout Flare Musculoskeletal Diseases
Conditions
Interventions
Participants will be randomised individually in a 1:1 ratio to oral prednisolone 30mg once daily (six 5mg tablets once daily) for five days or oral colchicine 0.5mg three times daily for four days (tw
the randomisation sequence will be computer-generated.
Sponsors
Keele University
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Current clinician-diagnosed gout flare 3. Fulfils Gaffo flare criteria, a validated definition of a gout flare requiring three out of four of: 3.1. Patient-defined flare (or clinician-defined flare if the patient had not had gout previously) 3.2. Pain score at rest of >3 on a 0–10 numeric rating score (NRS) 3.3. At least one swollen joint 3.4. At least one warm joint 4. Contraindication or caution to NSAIDs, defined as at least one of: 4.1. Age =65 years 4.2. Known estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m² 4.3. Prescribed anticoagulants 4.4. Allergy to aspirin or NSAID 4.5. Physician-diagnosed asthma 4.6. Physician-diagnosed peptic ulcer disease 4.7. Physician-diagnosed hypertension 4.8. Physician-diagnosed cardiovascular disease 4.9. Physician-diagnosed heart failure 4.10. Physician-diagnosed cerebrovascular disease
Exclusion criteria
Exclusion criteria: 1. Known eGFR 64 mmol/mol 4. Current active infection 5. Known blood dyscrasias 6. Severe hepatic impairment 7. Previous intolerance of or hypersensitivity to prednisolone or colchicine (or excipients) 8. Taken prednisolone or colchicine for a gout flare in the previous 72 hours 9. Currently prescribed prednisolone for another indication 10. Currently prescribed verapamil, diltiazem, macrolides, HIV protease inhibitors, azole anti-fungals or ciclosporin 11. Known galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 12. Pregnancy or breastfeeding 13. Women of childbearing potential unless using effective contraceptive measures* 14. Unable or unwilling to provide informed consent 15. Has been randomised in the trial for a previous flare 16. Currently taking part in another gout CTIMP *Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity from baseline as measured by worst pain intensity in the last 12 hours (0-10 NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain intensity (worst pain intensity in the last 12 hours (0-10 NRS)) is measured using self-report at baseline, days 1-7, week 2, week 3 and week 4 2. Joint swelling is measured using self-report at baseline, days 1-7, week 2, week 3 and week 4 3. Joint tenderness is measured using self-report at baseline, days 1-7, week 2, week 3 and week 4 4. Treatment side-effects are measured using self-report at days 1-7, week 2, week 3 and week 4 5. Treatment adherence is measured using self-report at days 1-7, week 2, week 3 and week 4 6. Treatment satisfaction is measured using self-report at day 7 and week 4 7. Physical function is measured using self-report at baseline, day 7 and week 4 8. Quality of life is measured using self-report at baseline, day 7 and week 4 9. Global assessment of treatment response is measured using self-report at day 7 and week 4 10. Flare relapse or recurrence is measured using self-report and defined as recurrence after 48 hours without a flare, assessed at week 4 11. Sleep is measured using self-report at baseline, days 1-7 and week 4 12. Use of walking aids is measured using self-report at baseline, day 7 and week 4 13. Analgesic use is measured using self-report at baseline, days 1-7, week 2, week 3 and week 4 14. Healthcare utilisation is measured using self-report at week 4 15. Work or education absence is measured using self-report at week 4 | — |
Countries
England, United Kingdom
Contacts
Public Contact. Occur Trial Team
Outcome results
None listed