Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05698680

PHASE4

Prednisolone Versus Colchicine for Acute Gout in Primary Care

Sponsor: University Medicine Greifswald

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

314

Start Date

2023-01-18

Completion Date

2026-02-28

Last Updated

2025-04-22

Healthy Volunteers

Conditions

Acute Gout

Interventions

DRUG

Prednisolone 30 mg Tablet

See treatment arm "Prednisolone"

DRUG

Colchicine 0.5 mg Oral Tablet

See treatment arm "Colchicine"

Locations (65)

Arztpraxis Burgtorstr. 2

Ittlingen, Baden-Wurttemberg, Germany

Hausarztpraxis Neckarsteinacher Str. 22

Neckargemünd, Baden-Wurttemberg, Germany

Hausarztpraxis Kleinfeldlein 3

Bad Bocklet, Bavaria, Germany

Hausarztpraxis Kapellenstraße 3

Bad Kissingen, Bavaria, Germany

Hausarztpraxis Ludwigstraße 18

Bad Kissingen, Bavaria, Germany

Hausarztpraxis Goethestraße 15 G

Bad Neustadt an der Saale, Bavaria, Germany

Hausarztpraxis Ahornstraße 1

Bischofsheim, Bavaria, Germany

Hausarztpraxis Mechenharder Straße 174

Erlenbach am Main, Bavaria, Germany

Hausarztpraxis Hauptstraße 12

Gössenheim, Bavaria, Germany

Hausarztpraxis Bahnhofstraße 24

Hammelburg, Bavaria, Germany

Hausarztpraxis Torgraben 3

Haßfurt, Bavaria, Germany

Hausarztpraxis Kaiserstraße 43

Kitzingen, Bavaria, Germany

Hausarztpraxis Rathausstraße 31

Leinach, Bavaria, Germany

Hausarztpraxis Herrngasse 11 A

Rimpar, Bavaria, Germany

Hausarztpraxis Spitalstr. 9

Schweinfurt, Bavaria, Germany

Hausarztpraxis Sulzdorfer Straße 6a

Stadtlauringen, Bavaria, Germany

Hausarztpraxis Dorfgraben 2a

Würzburg, Bavaria, Germany

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Hausarztpraxis Moltkestraße 5

Würzburg, Bavaria, Germany

Hausarztpraxis Point 3

Zellingen, Bavaria, Germany

Hausarztpraxis Wissmannstraße 14

Bad Lauterberg im Harz, Lower Saxony, Germany

Hausarztpraxis Hoher Weg 17

Bilshausen, Lower Saxony, Germany

Hausarztpraxis Bohlendamm 2

Gleichen, Lower Saxony, Germany

Hausarztpraxis Liererstr. 28

Goslar, Lower Saxony, Germany

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, Germany

Hausarztpraxis Ewaldstr. 40a

Göttingen, Lower Saxony, Germany

Hausarztpraxis Hennebergstr. 14a

Göttingen, Lower Saxony, Germany

Hausarztpraxis Backhausstraße 21

Göttingen, Lower Saxony, Germany

Hausarztpraxis Godehardtstraße 26

Göttingen, Lower Saxony, Germany

Hausarztpraxis Professor-Eberlein-Str. 6

Hannoversch Münden, Lower Saxony, Germany

Hausarztpraxis Steinstraße 19

Hannoversch Münden, Lower Saxony, Germany

Hausarztpraxis Vor dem Tore 2

Hardegsen, Lower Saxony, Germany

Hausarztpraxis Eckert Osteroder Str. 9

Herzberg am Harz, Lower Saxony, Germany

Hausarztpraxis Poppe Osteroder Str. 9

Herzberg am Harz, Lower Saxony, Germany

Hausarztpraxis Hauptstraße 34

Krebeck, Lower Saxony, Germany

Hausarztpraxis Neue Straße 22

Moringen, Lower Saxony, Germany

Hausarztpraxis Bahnhofstraße 6

Scheden, Lower Saxony, Germany

Hausarztpraxis Kampstr. 32

Seesen, Lower Saxony, Germany

Hausarztpraxis Bluthsluster Straße 2

Anklam, Mecklenburg-Vorpommern, Germany

Hausarztpraxis Am Westhafen 1

Barth, Mecklenburg-Vorpommern, Germany

Hausarztpraxis Schlossstraße 43

Dargun, Mecklenburg-Vorpommern, Germany

Krankenhaus Universitätsmedizin Greifswald