Prednisolone Versus Colchicine for Acute Gout in Primary Care

Launched by UNIVERSITY MEDICINE GREIFSWALD · Jan 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different medications, prednisolone and colchicine, to see which one works better for treating acute gout attacks. Gout is a painful condition that occurs when crystals form in the joints, leading to swelling and discomfort. The study will involve patients who have recently experienced an acute gout attack and will compare their pain levels after taking either medication. This trial is unique because it includes patients who might have been excluded from previous studies due to other health issues.

To be eligible for this study, participants must be adults aged 18 and older with a recent diagnosis of an acute gout attack. They should be experiencing pain, swelling, and tenderness in their hands or feet and have started feeling this pain within the last two days. Participants will take their assigned medication and then keep a daily diary to record their pain levels over the next few days. This study is currently recruiting, and it’s important to note that certain health conditions may prevent someone from participating. If you're interested or think you might qualify, it could be a good opportunity to help improve treatment options for gout.

Gender

ALL

Eligibility 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