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Prednisolone Versus Colchicine for Acute Gout in Primary Care

NCT05698680 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Acute Gout

Interventions

DRUG

Prednisolone 30 mg Tablet

See treatment arm "Prednisolone"

DRUG

Colchicine 0.5 mg Oral Tablet

See treatment arm "Colchicine"

Sponsors & Collaborators

  • University of Göttingen

    collaborator OTHER

  • Wuerzburg University Hospital

    collaborator OTHER

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Sylvia Stracke · University Medicine Greifswald

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05698680 on ClinicalTrials.gov