Prednisolone Versus Colchicine for Acute Gout in Primary Care
Megadott ok: The study was terminated due to an inability to reach the planned sample size, despite efforts to enhance recruitment.
A legfontosabb adatok
- Fázis
- 4. fázis
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálat adatai
- Ki végzi
- University Medicine Greifswald
- Azonosító
- NCT05698680EU 2024-514738-18-00
- A regiszteradat frissítve
- 2026. május 15.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Pragmatic, Randomized, Multicenter, Double-blind, Controlled, Clinical Trial of Prednisolone Versus Colchicine for Acute Gout in Primary Care
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.
Bevonási feltételek: 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.
Kizáró feltételek: Known intolerance or contraindication to either medication; Existing (or less than 2 weeks ago) oral treatment with corticosteroids or colchicine; Current chemotherapy or chemotherapy completed less than 3 months ago; Solid organ transplant with immune suppression; Known current gastric or duodenal ulcer (diagnosed in the last 4 weeks); Known HIV infection; 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; 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 intolerance to the placebo (e.g. lactose intolerance); Uncontrolled high blood pressure (systolic blood pressure permanently above 160 mmHg); 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.