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Comparing Prednisolone and Colchicine for Treating Acute Gout

Pragmatic, Randomized, Multicenter, Double-blind, Controlled, Clinical Trial of Prednisolone Versus Colchicine for Acute Gout in Primary Care

Phase 4 Interventional University Medicine Greifswald · NCT05698680

This study is testing if prednisolone works just as well as colchicine for treating sudden gout attacks in patients visiting their family doctors.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment314 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Medicine Greifswald Academic / other
Drugs / interventionschemotherapy
Locations65 sites (Ittlingen, Baden-Wurttemberg and 64 other locations)
Trial IDNCT05698680 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of prednisolone compared to colchicine in treating acute gout attacks in primary care settings. It is a pragmatic, prospective, double-blind, parallel-group, randomized, non-inferiority trial involving patients who present with acute gout symptoms to their general practitioners. The study aims to determine if prednisolone is as effective or only slightly less effective than colchicine, addressing a gap in previous research that primarily focused on specialized centers. The trial will take place across 60 practices in three university sites in Germany.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing an acute attack of gout with symptoms such as pain, swelling, and redness.

Not a fit: Patients with known contraindications to either prednisolone or colchicine, or those with severe chronic kidney disease, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from acute gout, particularly those with contraindications to traditional NSAIDs.

How similar studies have performed: While colchicine is commonly recommended for acute gout, this direct comparison with prednisolone has not been extensively studied, making this approach relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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)
* The onset of pain was no more than 2 days ago (e.g., presentation on Monday afternoon, onset of pain on Saturday morning)
* 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 g/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

Where this trial is running

Ittlingen, Baden-Wurttemberg and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute GoutPrimary carePrednisoloneColchicinePragmatic
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.