NCT05698680: COPAGO

Prednisolone Versus Colchicine for Acute Gout in Primary Care

Terminated Phase 4 Last updated 22 April 2025

What this trial tests

Phase 4 trial testing Prednisolone 30 mg Tablet in Acute Gout in 186 participants. Terminated before completion.

Timeline

18 January 2023

Primary endpoint
28 February 2026

28 February 2026

Quick facts

Lead sponsor	University Medicine Greifswald
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	186
Start date	18 January 2023
Primary completion	28 February 2026
Estimated completion	28 February 2026
Sites	65 locations across Germany

Drugs / interventions tested

• Prednisolone 30 mg Tablet
• Colchicine 0.5 mg Oral Tablet

Conditions studied

• Acute Gout — all drugs for Acute Gout →

Sponsor

University Medicine Greifswald

Who can join

18 and older, any sex, with Acute Gout. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prednisolone Versus Colchicine for Acute Gout in Primary Care (COPAGO): protocol for a two-arm multicentre, pragmatic, prospective, randomized, double-blind, controlled clinical trial of prednisolone and colchicine for non-inferiority with a parallel group design.
   Truthmann J, Freyer Martins Pereira J, Richter A, Schuster F, et al · · 2023 · cited 1× · PMID 37798801 · DOI 10.1186/s13063-023-07666-6
2. Prednisolone Versus Colchicine for Acute Gout in Primary Care: statistical analysis plan for the pragmatic, multicenter, randomized, and double-blinded COPAGO non-inferiority trial.
   Richter A, Truthmann J, Hummers E, Pereira JFM, et al · · 2024 · PMID 38570873 · DOI 10.1186/s13063-024-08066-0
3. Prednisolone Versus Colchicine for Acute Gout in Primary Care: statistical analysis plan for the pragmatic, multicenter, randomized, and double-blinded COPAGO non-inferiority trial
   Richter A, Truthmann J, Hummers E, Pereira JFM, et al · · 2024 · DOI 10.21203/rs.3.rs-3876128/v1
4. Prednisolone Versus Colchicine for Acute Gout in Primary Care (COPAGO). Protocol for a two-arm multicentre, pragmatic, prospective, randomised, double-blind, controlled clinical trial of prednisolone and colchicine for non-inferiority with a parallel group design.
   Truthmann J, Pereira JFM, Richter A, Schuster F, et al · · 2023 · DOI 10.21203/rs.3.rs-3150332/v1