Clinical Trial on the Treatment of Acute Gout Attacks in Primary Care
Acute gout attacks involving severe pain in a joint are almost always treated in primary care practices. Treatment recommendations are based on clinical experience, as there are only a few studies involving small numbers of patients from specialized centers.
The European League Against Rheumatism (EULAR) recommends colchicine as the first-line treatment for a gout attack. In contrast, the German Society for General Practice and Family Medicine (DEGAM) recommends prednisolone.
Both medications have been in use for a long time, but it is not yet clear which treatment is more effective and/or better tolerated.
Duration: July 1, 2022 – June 30, 2026
Project Objective
The objective of this study is to compare the effectiveness of colchicine and prednisolone in a primary care setting.
Study Design and Methodology
COPAGO is a pragmatic, randomized, multicenter, double-blind, controlled clinical trial comparing the treatment of acute gout attacks with prednisolone versus colchicine in primary care settings.
The study will be conducted in 60 primary care practices in Göttingen, Greifswald, and Würzburg and will include 314 participants. The diagnosis of acute gout (within the last 24 hours) is made by the participating physicians based on clinical presentation. Patients are randomly assigned to a treatment arm. Neither the physician nor the patient knows which of the two treatments is being administered (known as double-blind).
Intervention
Treatment:
The intervention group will be treated with 30 mg of prednisolone daily for 5 days. Participants in the control group will be treated with low-dose colchicine (Day 1: 1.5 mg; Days 2–5: 1.0 mg of colchicine each day).
Patient Diary:
All participants receive a patient diary in which, from Day 1 through Day 6,
pain, swelling, and tenderness of the affected joint, as well as any potential side effects, are recorded daily.
Final Medical Examination:
After approximately one week, participants return to their primary care physician’s office. They undergo a final examination and bring their completed patient diary with them.
Dual-energy computed tomography (optional):
Once the acute pain has subsided (usually after five to thirteen days), participants have the option to confirm the gout diagnosis using an imaging procedure. The costs are covered by the project.
Participating Institutions
- 60 family practice offices in and around Göttingen, Greifswald, and Würzburg
- Greifswald University Hospital (a public-law corporation), Department of General Medicine (sponsor)
- Göttingen University Hospital, Radiology / Institute for Diagnostic and Interventional Radiology (partner)
- Würzburg University Hospital, Department of General Medicine (partner)
Project Financing
The study is a “clinical drug trial” funded by the Federal Ministry of Education and Research.
Contact
contact information
- telephone: +49 551 3968193
- fax: +49 551 3929530
- e-mail address: allgemeinmedizin(at)med.uni-goettingen.de
contact information
- telephone: +49 551 3963393
- fax: +49 551 3929530
- e-mail address: petra.kamin(at)med.uni-goettingen.de
contact information
- telephone: +49 551 3965574
- fax: +49 551 3929530
- e-mail address: tanja.albrecht-nock(at)med.uni-goettingen.de
Studienkoordinatorin