Status:
COMPLETED
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Gout
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
Allopurinol is the standard of care for the treatment of gout. In practice, approximately 20% of patients report side effects with allopurinol and 5% discontinue allopurinol due to side effects. Allop...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT01508702
Start Date
January 1 2012
End Date
November 1 2013
Last Update
February 12 2016
Active Locations (106)
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1
Birmingham, Alabama, United States, 35211
2
Birmingham, Alabama, United States, 35294
3
Glendale, Arizona, United States, 85308
4
Phoenix, Arizona, United States, 85050