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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Pragmatic, randomized, multicentric, double-blind, controlled clinicial trial on the treatment of acute gout attacks with prednisolone versus colchicine in primary care (COPAGO)

This study, called COPAGO, is looking into how well two widely used medicines, prednisolone and colchicine, treat sudden attacks of gout. Gout causes severe pain, usually in a joint like the big toe. Researchers want to see which medicine is more effective at reducing this pain and other symptoms, such as swelling and tenderness. Participants will be given one of the two study medicines or a placebo (a dummy pill) without knowing which one, and neither will their doctor. This helps to make sure the results are fair. The study will track how pain changes over the first week and how well people can move. The goal is to provide clear information for doctors and patients in the UK about the best way to manage acute gout.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Universitaetsmedizin Greifswald KöR
Enrolment target
314
Start
20 Sep 2024

What is this study about?

When you have a sudden attack of gout, it can be incredibly painful. This study, called COPAGO, is designed to compare two common medicines often used to help with these painful flare-ups: prednisolone and colchicine. Both medicines are already used in standard care, but doctors want to understand which one works best, or if a combination is better, to get you feeling better faster.

The main thing researchers will be looking at is how much pain you experience in the first 24 hours after starting treatment. They will also check other important things like how much swelling and tenderness you have in your joint, how well you can move around, and your overall opinion on whether the treatment worked. They'll also note if you need to use other pain relief.

The reason this study is important is to help doctors make the best choices for their patients. By carefully comparing these existing treatments in a well-organised study, we can learn more about which one might be most effective for people in the UK experiencing acute gout attacks, leading to better pain management and quality of life.

Key takeaways

  • This study compares prednisolone and colchicine for acute gout attacks.
  • It aims to find out which medicine is better for pain relief and other symptoms.
  • Participants will be adults experiencing a gout flare-up.
  • The study uses a 'double-blind' method for fair results.
  • Your pain levels and joint symptoms will be closely monitored for about 6 days.
  • Your participation could help improve gout treatment for others.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or over. There's no upper age limit, so people of any adult age can join.

This study is for people who are currently experiencing an acute (sudden and severe) attack of gout. You will need to have a clear diagnosis of gout to be eligible for the study.

Unlike some studies, both men and women are welcome to participate. The study aims to gather information from a wide range of people who suffer from gout.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you currently having a sudden, painful attack of gout?
  3. Have you been diagnosed with gout by a doctor?
  4. Are you able to speak about your pain levels and other symptoms?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given one of the study medicines (prednisolone, colchicine, or a placebo) to take. You won't know which one you're getting, and neither will your doctor – this is a common practice in research to keep the results fair. You will need to keep track of your pain levels, especially the most severe pain you experience each day, for a period of about six days after starting the treatment.

Researchers will also assess your joint for swelling and tenderness. They'll ask you about how well you can move and do your daily activities. You might also be asked about any other pain medication you use or non-drug methods you try to ease your pain. The total duration of active follow-up for this study is quite short, focusing on the acute phase of the gout attack.

Potential risks and benefits

Taking part in this study might mean you get a medicine that helps reduce your gout pain and symptoms, potentially faster than if you weren't in the study. You'd also be contributing valuable information that could help others with gout in the future. As with any medicine, there's always a chance of side effects, which your doctor will explain fully. You also might receive a placebo, which means you might not get active treatment for your gout during this period. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Germany

Common questions

What is gout?

Gout is a type of arthritis that causes sudden, severe attacks of pain, swelling, redness, and tenderness in the joints, often the big toe.

What are prednisolone and colchicine?

Prednisolone is a steroid medicine that reduces inflammation. Colchicine is another medicine specifically used to treat and prevent gout attacks.

What does 'double-blind' mean?

It means neither you nor your doctor will know whether you're receiving prednisolone, colchicine, or a placebo (dummy pill). This helps make the study results fair.

Will I still be able to take my usual pain relief?

The study will track your use of additional pain medication, so you should discuss this with the study team. They will guide you on what is allowed and what needs to be recorded.

How long will I be involved in the study?

The main part of the study where your pain and symptoms are closely monitored is around 6 days during your acute gout attack.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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