Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors (LIGHT)
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|ClinicalTrials.gov Identifier: NCT01508702|
Recruitment Status : Completed
First Posted : January 12, 2012
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Gout||Drug: lesinurad Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled Study to Assess the Efficacy and Safety of Lesinurad Monotherapy Compared to Placebo in Subjects With Gout and an Intolerance or Contraindication to a Xanthine Oxidase Inhibitor|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||November 2013|
|Experimental: lesinurad 400 mg||
Tablets, 400 mg QD
|Placebo Comparator: placebo||
Tablets, Placebo QD
- Number of Subjects With an sUA Level That is < 6.0 mg/dL [ Time Frame: 6 months ]
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|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508702
|Study Director:||Chris Storgard, MD||Ardea Biosciences, Inc.|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Ardea Biosciences, Inc.|
|Other Study ID Numbers:||
2011-003756-39 ( EudraCT Number )
|First Posted:||January 12, 2012 Key Record Dates|
|Results First Posted:||February 12, 2016|
|Last Update Posted:||February 12, 2016|
|Last Verified:||July 2015|
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