Actively Recruiting
Prednisolone Versus Colchicine for Acute Gout in Primary Care
Led by University Medicine Greifswald · Updated on 2025-04-22
314
Participants Needed
65
Research Sites
162 weeks
Total Duration
On this page
Sponsors
U
University Medicine Greifswald
Lead Sponsor
U
University of Göttingen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prednisolone Versus Colchicine for Acute Gout in Primary Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years of age or older
- Clinical diagnosis of an acute gout attack with symptoms such as pain, swelling, tenderness, redness, or local warmth
- Acute pain located in the hand or foot
- Onset of pain within the last 2 days
- Willingness and ability to provide written informed consent
You will not qualify if you...
- Known intolerance or contraindication to prednisolone, colchicine, or placebo (e.g., lactose intolerance)
- Treatment with oral corticosteroids or colchicine within the last 2 weeks
- Chronic kidney disease stage 4 or higher, or estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m²
- Blood disorders such as low platelets (below 30,000/µl), low white blood cells (below 4000/µl), or low hemoglobin (below 5 mmol/l or 8 g/dl)
- Uncontrolled high blood pressure with systolic pressure above 160 mmHg
- Severe liver disease or liver enzyme levels more than twice the normal range
- Current stomach or duodenal ulcer diagnosed within 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
- Pregnancy or breastfeeding
- Participation in other clinical studies under the German Medicines Act within the last 3 months
- Previous participation in the COPAGO study with a past gout attack
AI-Screening
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Trial Site Locations
Total: 65 locations
1
Arztpraxis Burgtorstr. 2
Ittlingen, Baden-Wurttemberg, Germany, 74930
Actively Recruiting
2
Hausarztpraxis Neckarsteinacher Str. 22
Neckargemünd, Baden-Wurttemberg, Germany, 69151
Actively Recruiting
3
Hausarztpraxis Kleinfeldlein 3
Bad Bocklet, Bavaria, Germany, 97708
Actively Recruiting
4
Hausarztpraxis Kapellenstraße 3
Bad Kissingen, Bavaria, Germany, 97688
Actively Recruiting
5
Hausarztpraxis Ludwigstraße 18
Bad Kissingen, Bavaria, Germany, 97688
Actively Recruiting
6
Hausarztpraxis Goethestraße 15 G
Bad Neustadt an der Saale, Bavaria, Germany, 97616
Actively Recruiting
7
Hausarztpraxis Ahornstraße 1
Bischofsheim, Bavaria, Germany, 97653
Actively Recruiting
8
Hausarztpraxis Mechenharder Straße 174
Erlenbach am Main, Bavaria, Germany, 63906
Actively Recruiting
9
Hausarztpraxis Hauptstraße 12
Gössenheim, Bavaria, Germany, 97780
Actively Recruiting
10
Hausarztpraxis Bahnhofstraße 24
Hammelburg, Bavaria, Germany, 97762
Actively Recruiting
11
Hausarztpraxis Torgraben 3
Haßfurt, Bavaria, Germany, 97437
Actively Recruiting
12
Hausarztpraxis Kaiserstraße 43
Kitzingen, Bavaria, Germany, 97318
Actively Recruiting
13
Hausarztpraxis Rathausstraße 31
Leinach, Bavaria, Germany, 97274
Actively Recruiting
14
Hausarztpraxis Herrngasse 11 A
Rimpar, Bavaria, Germany, 97222
Actively Recruiting
15
Hausarztpraxis Spitalstr. 9
Schweinfurt, Bavaria, Germany, 97241
Actively Recruiting
16
Hausarztpraxis Sulzdorfer Straße 6a
Stadtlauringen, Bavaria, Germany, 97488
Actively Recruiting
17
Hausarztpraxis Dorfgraben 2a
Würzburg, Bavaria, Germany, 97076
Actively Recruiting
18
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
19
Hausarztpraxis Moltkestraße 5
Würzburg, Bavaria, Germany, 97082
Actively Recruiting
20
Hausarztpraxis Point 3
Zellingen, Bavaria, Germany, 97225
Actively Recruiting
21
Hausarztpraxis Wissmannstraße 14
Bad Lauterberg im Harz, Lower Saxony, Germany, 37431
Actively Recruiting
22
Hausarztpraxis Hoher Weg 17
Bilshausen, Lower Saxony, Germany, 37343
Actively Recruiting
23
Hausarztpraxis Bohlendamm 2
Gleichen, Lower Saxony, Germany, 37130
Actively Recruiting
24
Hausarztpraxis Liererstr. 28
Goslar, Lower Saxony, Germany, 38690
Actively Recruiting
25
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, Germany, 37073
Actively Recruiting
26
Hausarztpraxis Ewaldstr. 40a
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
27
Hausarztpraxis Hennebergstr. 14a
Göttingen, Lower Saxony, Germany, 37077
Actively Recruiting
28
Hausarztpraxis Backhausstraße 21
Göttingen, Lower Saxony, Germany, 37081
Actively Recruiting
29
Hausarztpraxis Godehardtstraße 26
Göttingen, Lower Saxony, Germany, 37081
Actively Recruiting
30
Hausarztpraxis Professor-Eberlein-Str. 6
Hannoversch Münden, Lower Saxony, Germany, 34346
Actively Recruiting
31
Hausarztpraxis Steinstraße 19
Hannoversch Münden, Lower Saxony, Germany, 34346
Actively Recruiting
32
Hausarztpraxis Vor dem Tore 2
Hardegsen, Lower Saxony, Germany, 37181
Actively Recruiting
33
Hausarztpraxis Eckert Osteroder Str. 9
Herzberg am Harz, Lower Saxony, Germany, 37412
Actively Recruiting
34
Hausarztpraxis Poppe Osteroder Str. 9
Herzberg am Harz, Lower Saxony, Germany, 37412
Actively Recruiting
35
Hausarztpraxis Hauptstraße 34
Krebeck, Lower Saxony, Germany, 37434
Actively Recruiting
36
Hausarztpraxis Neue Straße 22
Moringen, Lower Saxony, Germany, 37186
Actively Recruiting
37
Hausarztpraxis Bahnhofstraße 6
Scheden, Lower Saxony, Germany, 37127
Actively Recruiting
38
Hausarztpraxis Kampstr. 32
Seesen, Lower Saxony, Germany, 38723
Actively Recruiting
39
Hausarztpraxis Bluthsluster Straße 2
Anklam, Mecklenburg-Vorpommern, Germany, 17389
Actively Recruiting
40
Hausarztpraxis Am Westhafen 1
Barth, Mecklenburg-Vorpommern, Germany, 18356
Actively Recruiting
41
Hausarztpraxis Schlossstraße 43
Dargun, Mecklenburg-Vorpommern, Germany, 17159
Actively Recruiting
42
Krankenhaus Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Actively Recruiting
43
Hausarztpraxis Am Mühlentor 5
Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Actively Recruiting
44
Hausarztpraxis Anklamer Straße 66
Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Actively Recruiting
45
Hausarztpraxis Lange Straße 53
Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Actively Recruiting
46
Hausarztpraxis Markt 1
Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Actively Recruiting
47
Hausarztpraxis Ernst-Thälmann-Ring 66
Greifswald, Mecklenburg-Vorpommern, Germany, 17491
Actively Recruiting
48
Hausarztpraxis Schulstraße 1a
Groß Kiesow, Mecklenburg-Vorpommern, Germany, 17495
Actively Recruiting
49
Hausarztpraxis Pommersche Straße 18
Gützkow, Mecklenburg-Vorpommern, Germany, 17506
Actively Recruiting
50
Hausarztpraxis Prohner Straße 43
Klausdorf, Mecklenburg-Vorpommern, Germany, 18445
Actively Recruiting
51
Hausarztpraxis August-Levin-Straße 22c
Loitz, Mecklenburg-Vorpommern, Germany, 17121
Actively Recruiting
52
Hausarztpraxis Bahnhofstraße 16
Lübstorf, Mecklenburg-Vorpommern, Germany, 19069
Actively Recruiting
53
Hausarztpraxis Oberreihe 41
Lühmannsdorf, Mecklenburg-Vorpommern, Germany, 17495
Actively Recruiting
54
Hausarztpraxis Juri-Gagarin-Ring 24
Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
Actively Recruiting
55
Hausarztpraxis Störstraße 2
Plate, Mecklenburg-Vorpommern, Germany, 19086
Actively Recruiting
56
Hausarztpraxis Werdohler Straße 3
Stavenhagen, Mecklenburg-Vorpommern, Germany, 17153
Actively Recruiting
57
Hausarztpraxis Marienstraße 2-4
Stralsund, Mecklenburg-Vorpommern, Germany, 18439
Actively Recruiting
58
Hausarztpraxis Dorfstraße 57
Trent, Mecklenburg-Vorpommern, Germany, 18569
Actively Recruiting
59
Hausarztpraxis Birkenweg 5
Trinwillershagen, Mecklenburg-Vorpommern, Germany, 18320
Actively Recruiting
60
Hausarztpraxis Otto-Lilienthal-Straße 3
Trollenhagen, Mecklenburg-Vorpommern, Germany, 17039
Actively Recruiting
61
Hausarztpraxis Ueckerstraße 48
Ueckermünde, Mecklenburg-Vorpommern, Germany, 17373
Actively Recruiting
62
Hausarztpraxis Lange Straße 55
Waren, Mecklenburg-Vorpommern, Germany, 17192
Actively Recruiting
63
Hausarztpraxis Wilhelmstraße 3
Wolgast, Mecklenburg-Vorpommern, Germany, 17438
Actively Recruiting
64
Hausarztpraxis Lambertweg 6
Höxter, North Rhine-Westphalia, Germany, 37671
Actively Recruiting
65
Hausarztpraxis Straße der Einheit 56
Uder, Thuringia, Germany, 37318
Actively Recruiting
Research Team
J
Jean-François Chenot, MPH
CONTACT
J
Julia Truthmann, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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