Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors

Completed · Phase 3 · Has a placebo group

Conditions studied: Gout

In brief

This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.

Key facts

Study ID

NCT01508702

Run by

Ardea Biosciences, Inc.

People needed

214

Starts

2012-01-01

Expected to finish

2013-11-01

Last updated by the study team

2016-02-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
• Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
• Subject has an sUA level ≥ 6.5 mg/dL at the Screening and Day -7 Visits.
• Subject must be able to take gout flare prophylaxis with colchicine or NSAID (including Cox-2 selective NSAID) ± PPI.
• Subject has a history (either by medical record or subject interview) of intolerance or a contraindication to either allopurinol or febuxostat.
• Body mass index (BMI) < 45 kg/m2

You may not qualify if…

• Subject who is taking any other approved urate-lowering medication that is indicated for the treatment of gout at the Screening Visit.
• Subject with a documented history or suspicion of kidney stones.
• Subject who is pregnant or breastfeeding.
• Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
• Subject with a history or suspicion of drug abuse within the past 5 years.
• Subject that requires or may require systemic immunosuppressive or immunomodulatory treatment.
• Subject with a known or suspected human immunodeficiency virus (HIV) infection.
• Subject with a positive test for active hepatitis B or hepatitis C infection.
• Subject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.
• Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.
• Subject with uncontrolled hypertension.
• Subject with an estimated creatinine clearance < 30 mL/min.
• Subject with active peptic ulcer disease requiring treatment.
• Subject with active liver disease, or hepatic dysfunction.
• Subject receiving chronic treatment with more than 325 mg salicylates per day.
• Subject taking valpromide, progabide, or valproic acid.
• Subject who has received an investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit.
• Subject with any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Carmichael, California, United States
• Study site — Covina, California, United States
• Study site — Huntington Park, California, United States
• Study site — Irvine, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Milford, Connecticut, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Plant City, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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