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 (inclusive) at the time of signing the consent form.
• You have been diagnosed with gout (based on a specific set of medical guidelines) for at least 1 year.
• You have at least one tophus (a firm lump caused by uric acid buildup) on your hands, wrists, feet, or ankles that measures between 5mm and 30mm in size.
• Your uric acid levels in the blood were measured at 5.0 mg/dL or higher at two separate screening appointments.
• If you are a woman who could become pregnant, you must have had negative pregnancy tests at two screening visits and on Day 1 of the trial, and must not be breastfeeding.
• If you are a man who could father a child, or a woman who could become pregnant, you must agree to either abstain from heterosexual sex or use an approved 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 within the past year.
• You have had a cancer diagnosis in the last 5 years, except for certain treated skin cancers (basal cell or squamous cell carcinoma).
• You have had an allergic reaction or intolerance to the study drug (dotinurad), colchicine, or anti-inflammatory pain medications known as NSAIDs (such as ibuprofen).
• You have a known or suspected history of drug misuse, tested positive for drugs at your first screening visit, or have a recent history of alcohol misuse.
• You have a known history of, or tested positive during screening for, HIV, Hepatitis B, or Hepatitis C.

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