Prednisolone Versus Colchicine for Acute Gout in Primary Care
Status:
Not yet recruiting
Trial end date:
2026-02-28
Target enrollment:
Participant gender:
Summary
Gout is the most common form of rheumatic disease in which monosodium urate crystals are
deposited in the joints followed by acute inflammatory reactions. There are various approved
drugs that can be prescribed for pain relief during an acute gout attack. However to date, no
direct comparison of efficacy of colchicine and prednisolone for the treatment of acute gout
attacks has been investigated. Furthermore, majority of previous research studies were not
only conducted in tertiary centres but also excluded patients with common comorbidities due
to contraindications with naproxen.
This pragmatic, prospective, double-blind, parallel-group, randomized, non-inferiority trial
will investigate whether prednisolone (treatment drug) is comparable or only acceptably worse
than treatment with colchicine (comparison drug) in patients presenting with acute gout.
Patients presenting with acute gout to their general practitioners in 60 practices across 3
university sites (Greifswald, Göttingen, and Würzburg) will be invited to participate.
Patients often excluded by previous studies due to contraindications with naproxen will also
be able to participate. The investigators will compare the absolute levels of the most severe
pain on day 3 (in the last 24 hours) measured with an 11-item numerical rating scale as the
primary endpoint. Day 0 is the day patients take their study medication for the first time.
They are then asked to fill out a study diary at the same time each day to quantify their
pain. Pain scores will then be used as comparison between the two medications.
Phase:
Phase 4
Details
Lead Sponsor:
University Medicine Greifswald
Collaborators:
University of Göttingen Wuerzburg University Hospital