Phase 3 Gout Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing to take part and sign a consent form agreeing to participate.
• If you are a woman who could become pregnant and is sexually active, you must be willing to use an accepted form of contraception (such as condoms or hormonal methods) during the study.
• You have a history of high uric acid levels (above 7 mg/dL), either recorded in your medical notes or reported by you.
• You have been clinically diagnosed with an acute gout attack, based on a scoring system that considers factors such as being male, having had a similar gout attack before, joint redness, which joint is affected, and whether you have high blood pressure or a heart condition (confirm with trial site for exact score needed).
• You are currently experiencing a severe, painful gout flare-up with swelling, inflammation, and redness in the affected joint that started no more than 48 hours ago.
• The doctor running the trial believes you are suitable for the study treatment and may benefit from it.

Who may not be able to join:

• You are currently taking part in another clinical trial or have done so within the past two weeks.
• There are concerns that something about your situation could unfairly influence your participation, such as working for the research centre or sponsor (confirm with trial site).
• You have a medical condition that, in the doctor's opinion, affects your outlook and means you cannot be treated as an outpatient.
• You have a serious, worsening, or unstable long-term illness that could affect the study results or put you at risk.
• You are pregnant or currently breastfeeding.
• The study medication is not medically suitable for you for any reason.
• You have a history of a bad reaction, intolerance, or allergy to anti-inflammatory painkillers (NSAIDs), paracetamol, or any ingredient in the study medication.
• You have a significant history of stomach or bowel problems, such as stomach ulcers, Crohn's disease, ulcerative colitis, or gastrointestinal bleeding.
• You have a history of moderate-to-severe heart failure, established heart disease, poor circulation in the legs, or a history of stroke or related conditions, including recent heart surgery or procedures.
• You have used steroid tablets or injections to treat a gout attack within the past two weeks.
• You have taken anti-inflammatory painkillers (NSAIDs) in the 48 hours before joining the study, unless it was low-dose aspirin for heart protection.
• You have previously tried a specific type of anti-inflammatory medication called a COX-2 inhibitor and it did not work for you.
• Your current gout attack affects more than four joints at the same time.
• You have had problems with alcohol or drug misuse in the past year.
• There is reason to suspect your joint pain may be caused by an infection or a different joint condition rather than gout.
• You have a history of chronic liver failure of any severity.
• You have a history of significant chronic kidney disease (with a kidney filtration rate below 30 ml/min/1.73 m²).
• You have a known blood clotting disorder (such as haemophilia or Von Willebrand disease) or you take blood-thinning medication.
• You have or have had cancer (other than a type of minor skin cancer called basal cell carcinoma), a severe illness with a life expectancy of less than one year, or a mental health condition.
• You currently have symptoms that suggest you may have COVID-19 (such as fever, cough, or breathlessness), or you have been in close contact with a confirmed or suspected COVID-19 case in the past 14 days.

Important: Always verify eligibility with the trial site directly before applying.