Pragmatic, Randomized, Multicenter, Double-blind, Controlled, Clinical Trial of Prednisolone Versus Colchicine for Acute Gout in Primary Care

Status: Recruiting
Location: See all (65) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Hausarztpraxis Bluthsluster Straße 2
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Anklam
Hausarztpraxis Kleinfeldlein 3
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Bad Bocklet
Hausarztpraxis Kapellenstraße 3
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Bad Kissingen
Hausarztpraxis Ludwigstraße 18
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Bad Kissingen
Hausarztpraxis Wissmannstraße 14
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Bad Lauterberg Im Harz
Hausarztpraxis Goethestraße 15 G
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Bad Neustadt An Der Saale
Hausarztpraxis Am Westhafen 1
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Barth
Hausarztpraxis Hoher Weg 17
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Bilshausen
Hausarztpraxis Ahornstraße 1
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Bischofsheim
Hausarztpraxis Schlossstraße 43
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Dargun
Hausarztpraxis Mechenharder Straße 174
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Erlenbach Am Main
Hausarztpraxis Bohlendamm 2
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Gleichen
Hausarztpraxis Liererstr. 28
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Goslar
Hausarztpraxis Hauptstraße 12
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Gössenheim
Hausarztpraxis Backhausstraße 21
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Göttingen
Hausarztpraxis Ewaldstr. 40a
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Göttingen
Hausarztpraxis Godehardtstraße 26
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Göttingen
Hausarztpraxis Hennebergstr. 14a
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Göttingen
Universitätsmedizin Göttingen
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Göttingen
Hausarztpraxis Am Mühlentor 5
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Greifswald
Hausarztpraxis Anklamer Straße 66
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Greifswald
Hausarztpraxis Ernst-Thälmann-Ring 66
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Greifswald
Hausarztpraxis Lange Straße 53
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Greifswald
Hausarztpraxis Markt 1
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Greifswald
Krankenhaus Universitätsmedizin Greifswald
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Greifswald
Hausarztpraxis Schulstraße 1a
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Groß Kiesow
Hausarztpraxis Pommersche Straße 18
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Gützkow
Hausarztpraxis Bahnhofstraße 24
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Hammelburg
Hausarztpraxis Professor-Eberlein-Str. 6
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Hannoversch Münden
Hausarztpraxis Steinstraße 19
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Hannoversch Münden
Hausarztpraxis Vor dem Tore 2
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Hardegsen
Hausarztpraxis Torgraben 3
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Haßfurt
Hausarztpraxis Eckert Osteroder Str. 9
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Herzberg Am Harz
Hausarztpraxis Poppe Osteroder Str. 9
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Herzberg Am Harz
Hausarztpraxis Lambertweg 6
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Höxter
Arztpraxis Burgtorstr. 2
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Ittlingen
Hausarztpraxis Kaiserstraße 43
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Kitzingen
Hausarztpraxis Prohner Straße 43
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Klausdorf
Hausarztpraxis Hauptstraße 34
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Krebeck
Hausarztpraxis Rathausstraße 31
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Leinach
Hausarztpraxis August-Levin-Straße 22c
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Loitz
Hausarztpraxis Bahnhofstraße 16
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Lübstorf
Hausarztpraxis Oberreihe 41
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Lühmannsdorf
Hausarztpraxis Neue Straße 22
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Moringen
Hausarztpraxis Neckarsteinacher Str. 22
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Neckargemünd
Hausarztpraxis Juri-Gagarin-Ring 24
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Neubrandenburg
Hausarztpraxis Störstraße 2
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Plate
Hausarztpraxis Herrngasse 11 A
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Rimpar
Hausarztpraxis Bahnhofstraße 6
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Scheden
Hausarztpraxis Spitalstr. 9
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Schweinfurt
Hausarztpraxis Kampstr. 32
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Seesen
Hausarztpraxis Sulzdorfer Straße 6a
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Stadtlauringen
Hausarztpraxis Werdohler Straße 3
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Stavenhagen
Hausarztpraxis Marienstraße 2-4
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Stralsund
Hausarztpraxis Dorfstraße 57
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Trent
Hausarztpraxis Birkenweg 5
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Trinwillershagen
Hausarztpraxis Otto-Lilienthal-Straße 3
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Trollenhagen
Hausarztpraxis Straße der Einheit 56
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Uder
Hausarztpraxis Ueckerstraße 48
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Ueckermünde
Hausarztpraxis Lange Straße 55
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Waren
Hausarztpraxis Wilhelmstraße 3
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Wolgast
Hausarztpraxis Dorfgraben 2a
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Würzburg
Hausarztpraxis Moltkestraße 5
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Würzburg
Universitätsklinikum Würzburg
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Würzburg
Hausarztpraxis Point 3
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Zellingen
Contact Information
Primary
Jean-François Chenot, MPH
Jean-Francois.Chenot@med.uni-greifswald.de
00493834 86
Backup
Julia Truthmann, MSc
Julia.Truthmann@med.uni-greifswald.de
00493834 86
Time Frame
Start Date: 2023-01-18
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 314
Treatments
Experimental: Prednisolone 30mg (Day 0-4)
As both drugs have different dosing regimens, the investigators provide identical blisters for both drugs including the active substance and corresponding placebos. This way, all study participants receive the same number of tablets and the possibility of drug prediction is more difficult. This is achieved by using tablets that are identical in taste and appearance (double-dummy design). Participants randomised to the prednisolone arm will receive prednisolone plus a colchicine placebo. The prednisolone placebos contain a bittering agent due to the bitter taste of prednisolone to ensure a similar taste.~The dosage is according to EULAR guideline and also within the recommended range of the DEGAM guideline. The cumulative total dose taken per participant within the clinical trial is 150 mg for prednisolone.
Active_comparator: Colchicine 1.5 mg (Day 0), 1.0 mg (Day 1-4)
As both drugs have different dosing regimens, the investigators provide identical blisters for both drugs including the active substance and corresponding placebos. This way, all study participants receive the same number of tablets and the possibility of drug prediction is more difficult. This is achieved by using tablets that are identical in taste and appearance (double-dummy design). Participants randomised to the colchicine arm will receive colchicine plus prednisolone placebo.~The dosage is according to EULAR guideline and also within the recommended range of the DEGAM guideline. The cumulative total dose taken per participant within the clinical trial is 5.5mg for colchicine.
Related Therapeutic Areas
Sponsors
Collaborators: University of Göttingen, Wuerzburg University Hospital
Leads: University Medicine Greifswald

This content was sourced from clinicaltrials.gov