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Study on Treating Acute Gout Attacks with Prednisolone and Colchicine for Primary Care Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of acute gout attacks, a condition characterized by sudden and severe pain in the joints, often affecting the hand or foot. The study compares two treatments: Prednisolone and Colchicine. Prednisolone is a type of medication known as a glucocorticosteroid, which helps reduce inflammation and pain. Colchicine is another medication used to treat gout by reducing swelling and pain.

The purpose of the study is to evaluate the effectiveness of these treatments in managing the most severe pain experienced during an acute gout attack. Participants in the study will receive either Prednisolone, Colchicine, or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers know which treatment each participant is receiving, to ensure unbiased results.

Throughout the study, participants will take the medication orally for a period of up to five days. Researchers will monitor the participants' pain levels, joint swelling, and overall physical function. The study aims to determine which treatment provides the best relief from pain and improves joint function during an acute gout attack. Participants' feedback on the success of the treatment and any additional pain relief methods used will also be collected to provide a comprehensive understanding of the treatment's effectiveness.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years and over), acute pain in the hand or foot, and a clinical diagnosis of an acute gout attack. The onset of pain must have occurred no more than 2 days ago.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. This process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered to ensure unbiased results.

  3. Step 3

    Treatment administration

    Participants receive either prednisolone or colchicine orally. The specific dosage and frequency are determined by the study protocol, which is not detailed here.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for their response to treatment from day 1 to day 6. This includes assessing the most severe pain experienced in the last 24 hours, swelling and tenderness of the joint, and physical function on day 6 compared to the baseline.

  5. Step 5

    Assessment of treatment success

    Participants provide an overall assessment of the success of the treatment. The frequency of additional pain medication use and non-drug pain therapies is also recorded.

Who can join the trial?

5 criteria

  • Adult patients aged 18 years and over
  • Experiencing acute pain in the hand or foot. Acute pain means sudden and severe pain.
  • The start of the pain was no more than 2 calendar days ago
  • A clinical diagnosis of an acute attack of gout. This means a doctor has confirmed that you have a sudden gout attack.
  • Willingness to participate in the study and ability to give written informed consent. This means you agree to join the study and can sign a form saying you understand what it involves.

Who cannot join the trial?

4 criteria

  • Patients who are not experiencing a gout attack cannot participate. A gout attack is a sudden and severe pain in the joints, often in the big toe.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are not experiencing severe pain in the last 24 hours cannot participate. Severe pain is measured on a scale from 0 to 10, where 10 is the worst pain imaginable.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or people with certain disabilities.
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Investigated drugs

  • Prednisolone

    is a medication used in this trial to treat acute gout attacks. It is a type of corticosteroid that helps reduce inflammation and relieve pain. In the context of this study, it is being compared to another treatment to see how effective it is in managing the severe pain associated with gout.

  • Colchicine

    is another medication being tested in this trial for the treatment of acute gout attacks. It works by reducing the inflammation caused by gout, which helps to alleviate pain. This study aims to compare its effectiveness against another treatment option to determine the best approach for managing gout pain.

What is already known about the treatment

  • Prednisolone

    Prednisolone is typically administered orally in tablet form. It is a well-established medication in the medical field, widely documented in literature for its anti-inflammatory properties. It is primarily used to treat conditions like acute gout attacks by reducing inflammation and pain. At the molecular level, prednisolone works by suppressing the immune system and decreasing the production of substances that trigger inflammation. It is classified as a corticosteroid.

  • Colchicine

    Colchicine is usually taken orally in tablet form. It is a long-standing medication in medical practice, with extensive literature supporting its use. It is mainly indicated for the treatment of acute gout attacks, helping to relieve pain and inflammation. Colchicine acts at the molecular level by disrupting the formation of microtubules, which in turn reduces the activity of white blood cells that contribute to inflammation. It is classified as an anti-gout agent.

Investigated diseases

Gout – Gout is a type of arthritis characterized by sudden, severe attacks of pain, redness, and swelling in the joints, often affecting the big toe. It occurs when urate crystals accumulate in the joint, causing inflammation and intense pain. These crystals form when there are high levels of uric acid in the blood. An acute gout attack typically begins at night and can last for several days, with the most severe pain occurring within the first 24 hours. The affected joint becomes hot, swollen, and extremely tender, making movement difficult. Over time, repeated attacks can lead to joint damage and decreased mobility.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514738-18-00Protocol code202102COPAGOEstimated enrolment314 patientsSponsorUniversitaetsmedizin Greifswald KöR

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).