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 having a gout attack that started no more than 5 days ago, diagnosed using standard medical criteria
• The gout attack is affecting one or more joints in your arms or legs (such as your foot, knee, or wrist)
• This is either your first gout attack, or a new attack where you have not been taking uric acid-lowering medication for at least 6 months
• Your blood uric acid level is at or above a certain threshold (420 µmol/l), measured within the last 10 days
• You are 18 years old or older
• Your kidneys are working well enough (creatinine clearance at or above 30 ml/min), measured within the last 10 days
• You have read, understood, and signed the consent form for the study
• You are covered by a social security scheme (French healthcare system)
• If you are a woman who could become pregnant, you are using an effective form of contraception (such as the pill, an IUD, or tubal ligation for more than 1 month) and have a negative pregnancy test at the start and throughout the study
• If you are a woman, you are post-menopausal, meaning your periods stopped naturally at least 12 months before joining the study

Who may not be able to join:

• You are under 18 years old
• You stopped taking uric acid-lowering medication less than 6 months ago
• You have a known allergy or sensitivity to febuxostat (the study drug, sold as ADENURIC) or any of its ingredients
• Your kidneys are not working well enough (creatinine clearance below 30 ml/min)
• You have a liver condition shown by significantly abnormal liver test results (confirm with trial site)
• You currently have an alcohol dependency that is untreated
• Your gout attack started more than 5 days ago
• You have had an organ or bone marrow transplant
• You are currently taking certain medications, including Naproxen, mercaptopurine, azathioprine, theophylline, certain antibiotics (macrolides), certain cholesterol-lowering drugs (statins), some blood pressure medications in combination with diuretics, or certain other drugs that affect how the body processes medicines (confirm with trial site)
• You have a rare inherited condition affecting how your body handles certain sugars, such as galactose intolerance, lactase deficiency, or glucose/galactose malabsorption
• You have difficulty understanding the study due to a neurological condition or because French is not sufficiently understood
• You are pregnant, likely to be pregnant, or not using effective contraception (a negative pregnancy test is required)
• You are currently breastfeeding
• You have a history of a serious uncontrolled heart condition (such as a heart attack, stroke, or unstable angina), or uncontrolled metabolic, hormonal, psychiatric, or cancer-related illness
• You are currently under an administrative or legal order restricting your freedom
• You are under legal guardianship or a court-appointed form of protection
• You have taken part in another clinical drug trial in the month before joining this study

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