Prednisolone Versus Colchicine for Acute Gout in Primary Care

• Status: Not yet recruiting
• Trial end date: 2026-02-28
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medicine Greifswald
• Collaborators: University of Göttingen; Wuerzburg University Hospital
• Treatments: Colchicine; Prednisolone

Criteria

Inclusion Criteria:

• Adult patients ≥ 18 years of age

• Clinical diagnosis of acute attack of gout (symptoms: pain, swelling, tenderness, redness or local hyperthermia).

• Acute pain in hand or foot (podagra, chiragra) (existing since the previous day at the most)

• Willingness to participate in the study and ability to give written informed consent.

Exclusion Criteria:

• Known intolerance or contraindication to either medication

• Known intolerance to the placebo (e.g. lactose intolerance).

• Existing (or less than 2 weeks ago) oral treatment with corticosteroids or colchicine.

• Known chronic kidney disease (CKD stage 4 or greater) or an available value of estimated glomerular filtration rate (eGFR) < 30ml/min/1.73 m².

• Known haematopoietic disorder or available values of platelets < 30,000 µl or leucocytes < 4000 µl, or Hb <5 mmol/l/ or 8 mg/dl

• Uncontrolled high blood pressure (systolic blood pressure permanently above 160 mmHg).

• Known liver cirrhosis or severe liver disease or available liver enzymes results (ie. Serum Glutamate Oxalate Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase(SGPT)) being elevated by more than twice the respective reference range

• Known current gastric or duodenal ulcer (diagnosed in the last 4 weeks)

• Current chemotherapy or chemotherapy completed less than 3 months ago

• Known HIV infection

• Solid organ transplant with immune suppression

• Desire to have children within the next 6 months in both men and women

• Existing pregnancy or breastfeeding

• Participation in other studies according to the German Medicines Act in the last 3 months

• Participation in the COPAGO study with past gout attack