Status:
RECRUITING
Prednisolone Versus Colchicine for Acute Gout in Primary Care
Lead Sponsor:
University Medicine Greifswald
Collaborating Sponsors:
University of Göttingen
Wuerzburg University Hospital
Conditions:
Acute Gout
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
SCIENTIFIC BACKGROUND: Gout is one of the most common rheumatic diseases, affecting 3-6% of men and 1-2% of women in western countries. Due to the severe pain and impaired quality of life, the indivi...
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
Key Trial Info
Start Date :
January 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT05698680
Start Date
January 18 2023
End Date
February 28 2026
Last Update
April 22 2025
Active Locations (65)
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1
Arztpraxis Burgtorstr. 2
Ittlingen, Baden-Wurttemberg, Germany, 74930
2
Hausarztpraxis Neckarsteinacher Str. 22
Neckargemünd, Baden-Wurttemberg, Germany, 69151
3
Hausarztpraxis Kleinfeldlein 3
Bad Bocklet, Bavaria, Germany, 97708
4
Hausarztpraxis Kapellenstraße 3
Bad Kissingen, Bavaria, Germany, 97688