RecruitingPhase IVInterventional

Oral corticosteroids and colchicine for the treatment of gout flares (OCCUR)

Gout affects many people in the UK, causing painful joint flares. While strong painkillers like ibuprofen are often used, many people can't take them. For these individuals, doctors typically prescribe either colchicine or steroid tablets. This study, called OCCUR, aims to discover which of these two medications is more effective at relieving gout flare pain, leads to fewer side effects, and is the most cost-effective for the NHS. By comparing these treatments, the study hopes to improve care for people with gout flares who need alternative pain relief. It involves 280 adults who are currently experiencing a gout flare and cannot use standard painkillers.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

Keele University

Enrolment target

280

Start

17 Nov 2025

Estimated completion

01 Oct 2027

Gout Flare

What is this study about?

Gout is a common condition in the UK that causes sudden and severe pain and swelling in the joints, known as a gout flare. These flares can be very debilitating and significantly affect a person's quality of life. Usually, doctors treat gout flares with anti-inflammatory painkillers like ibuprofen. However, many people with gout also have other health problems, which means they can't safely take these types of medications.

For those who can't use standard painkillers, doctors usually prescribe either colchicine or steroid tablets. At the moment, we don't know for sure which of these two treatments works better for reducing pain during a gout flare or which one causes fewer unwanted side effects. We also want to understand which option provides better value for money for the NHS.

This study, called OCCUR, aims to answer these important questions. By comparing colchicine and steroid tablets in real-world settings, we hope to provide clear information that will help doctors and patients make the best treatment choices for gout flares in the future.

Key takeaways

This study compares two common gout treatments: colchicine and steroid tablets.
It's for people experiencing a gout flare who can't take standard painkillers like ibuprofen.
The goal is to find out which treatment is most effective, has fewer side effects, and is best value for money.
Participation involves taking one of the assigned medicines, filling out pain diaries, and answering questionnaires for 4 weeks.
Both medications are already approved and widely used, but the study helps us understand which is better in this specific situation.

Who may be eligible?

To be part of this study, you need to be an adult aged 18 or older and currently experiencing a gout flare that has been diagnosed by a doctor. Your pain level should be at least 'moderate' when resting, and you should have at least one swollen and warm joint. A key requirement is that you must not be able to take standard anti-inflammatory painkillers (NSAIDs) for reasons like your age (65 or over), kidney issues, taking blood thinners, having asthma or stomach ulcers, or certain heart conditions.

There are also some reasons why you might not be able to join. These include severe kidney problems, having had an organ transplant, poorly managed diabetes, current infections, certain blood or liver problems, or if you've had a bad reaction to prednisolone or colchicine before. You also can't participate if you're currently taking certain medications that might interact with the study drugs, are pregnant or breastfeeding, or have been in this study before for another flare.

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.

Are you 18 years old or older?
Do you currently have a doctor-diagnosed gout flare with pain, swelling, and warmth?
Are you unable to take standard anti-inflammatory painkillers (NSAIDs) for reasons like age (65+), kidney problems, or other health conditions?
Have you not taken prednisolone or colchicine for a gout flare in the last 72 hours?
Are you not pregnant or breastfeeding, and using effective contraception if applicable?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be one of 280 adults experiencing a gout flare who can't take certain painkillers. You'll be randomly assigned to receive either colchicine or steroid tablets to treat your flare. The study plans to involve around 100 doctor's surgeries across different areas.

Your involvement will include completing a few questionnaires and a pain diary. First, you'll complete a questionnaire at the start, either online or over the phone, which should take about 30 minutes. For the first 7 days of your flare, you'll need to fill out a short pain diary twice a day (about 5 minutes each time). Then, you'll complete shorter questionnaires online or on paper at weeks 1, 2, and 3 (about 10-15 minutes each) and a final, slightly longer questionnaire at week 4 (about 30 minutes). You will still have access to your usual healthcare and receive a leaflet about managing gout, including self-care tips.

Potential risks and benefits

The medications used in this study, colchicine and steroid tablets (prednisolone), are commonly prescribed and have been approved for treating gout flares in the UK. Therefore, your GP will use their judgment to ensure these treatments are suitable for you before you join. While there isn't a guaranteed benefit to you personally, your participation will help us understand which treatment works best for gout, potentially improving care for many people in the future. As with all medications, there's a chance of side effects. Colchicine can cause diarrhoea, nausea, or vomiting. Prednisolone might lead to heartburn, indigestion, feeling hyperactive, or disturbed sleep or mood. Your GP will explain these potential side effects and what to do if you experience any. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

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

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Unverified
United Kingdom

Common questions

What is gout?

Gout is a type of arthritis that causes sudden, severe pain, swelling, and redness in a joint, usually the big toe.

What does 'randomised' mean?

It means you'll be assigned to one of the treatment groups (colchicine or steroids) by chance, like flipping a coin. Neither you nor your doctor will choose which one you get.

How long will I be in the study?

You'll be actively involved for about 4 weeks, completing diaries and questionnaires during that time.

What if I'm taking other medicines?

Your doctor will check if your current medicines are compatible with the study treatments before you join. You may need to temporarily pause some medications, like certain statins, if assigned colchicine, as per usual NHS advice.

Who is paying for this research?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

. Occur Trial Team

ctu.occur@keele.ac.uk - Official trial record

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