Expired Study
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Clinical Trial 10544

Winter Park, FL 32789

Study Summary:

A multicenter, randomized, double-blind, phase 2 study to evaluate the effect of an investigational medication in joint damage in hyperuricemic subjects with early gout.

Qualified Participants Must:

• Have a history or presence of gout defined as having one or more of the following conditions of the American Rheumatism Association (ARA) preliminary criteria for the diagnosis of gout.

  • A tophus proven to contain urate crystals by chemical or polarized light microscopic means and/or
  • Characteristic urate crystals in the joint fluid and/or
  • History of at least 6 of the following clinical, laboratory and x-ray phenomena*:
    maximum inflammation developed within 1 day
    monoarticular arthritis
    redness observed over joints
    first metatarsophalangeal joint painful or swollen
    unilateral first metatarsophalangeal joint attack
    unilateral tarsal joint attack
    tophus (proven or suspected)
    asymmetric swelling within a joint on x-ray
    sub-cortical cysts without erosions on x-ray
    joint fluid culture negative for organisms during attacks

• Have more than one flare criteria that has been excluded for the purpose of this study
• If male, be at least 18 years of age
• If female, be 45 years of age or older and be at least 2 years post-menopausal AND have a Follicle Stimulating Hormone (FSH) level ≥40IU/L OR
• If female and receiving hormone replacement therapy (HRT), be ≥55 years of age (FSH level not required)
• Have hyperuricemia defined as sUA level ≥7.0 mg/dL at screening
• Have a history of (one) single acute gout flare located within right or left MTP, IP, ankle, MCP, PIP, or DIP joints prior to screening

Qualified Participants May Receive:

All study related medication and healthcare at no cost. Eligible participants will be compensated for their time and travel.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.