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 between 18 and 75 years old at the time of signing the consent form.
• You have been formally diagnosed with gout for at least 1 year, based on recognised medical guidelines.
• You have had at least 2 gout flare-ups in the past 12 months, either reported by you or recorded in your medical notes.
• You have been taking a steady dose of allopurinol (at least 300 mg/day, or at least 200 mg/day if you have moderate kidney problems) for at least 3 months before the screening visit, and you are able to continue this dose up to the start of the trial.
• Your uric acid blood level is at or above a certain level (6.5 mg/dL) at two separate screening appointments.
• If you are a woman who could become pregnant, you must have a negative pregnancy test at two screening visits and on the first day of the trial, and you must not be breastfeeding.
• If you could father or become pregnant, you must agree to either avoid heterosexual sex or use an accepted form of contraception from signing the consent form until 30 days after your last dose of the study drug.

Who may not be able to join:

• You have had kidney stones in the past year.
• You have been diagnosed with most types of cancer in the last 5 years (some treated skin cancers may be an exception — confirm with trial site).
• You have a known allergy or intolerance to the study drug (dotinurad), or to both colchicine and anti-inflammatory pain relievers (such as ibuprofen).
• You have a known history of drug misuse, tested positive for drugs at the first screening visit, or have a recent history of alcohol misuse.
• You have HIV, Hepatitis B, or Hepatitis C, or test positive for these during screening.
• You have any significant health condition or illness that the trial doctor believes could put you at risk, affect your ability to follow the trial rules, or make the results harder to interpret.

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