Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01508702




Registration number
NCT01508702
Ethics application status
Date submitted
10/01/2012
Date registered
12/01/2012
Date last updated
12/02/2016

Titles & IDs
Public title
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
Scientific 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
Secondary ID [1] 0 0
2011-003756-39
Secondary ID [2] 0 0
RDEA594-303
Universal Trial Number (UTN)
Trial acronym
LIGHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lesinurad
Treatment: Drugs - Placebo

Experimental: lesinurad 400 mg -

Placebo comparator: placebo -


Treatment: Drugs: lesinurad
Tablets, 400 mg QD

Treatment: Drugs: Placebo
Tablets, Placebo QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With an sUA Level That is < 6.0 mg/dL
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
214
Recruitment in Australia
Recruitment state(s)
QLD,TAS
Recruitment hospital [1] 0 0
- Butterfield
Recruitment hospital [2] 0 0
- Hobart
Recruitment hospital [3] 0 0
- Tasmania
Recruitment postcode(s) [1] 0 0
4029 - Butterfield
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
7000 - Tasmania
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
State/province [4] 0 0
California
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United States of America
State/province [5] 0 0
Colorado
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Kentucky
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Louisiana
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Michigan
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Mississippi
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United States of America
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Missouri
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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West Virginia
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Belgium
State/province [31] 0 0
Brussels
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Belgium
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Limburg
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Belgium
State/province [33] 0 0
Gozee
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Belgium
State/province [34] 0 0
Kortrijk
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Belgium
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Yvoir
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Germany
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Saxony
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Germany
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Dresden
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New Zealand
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Bay of Plenty
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New Zealand
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Auckland
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South Africa
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Durban
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South Africa
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Pretoria
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South Africa
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Rondebosch
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South Africa
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Stellenbosch
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South Africa
State/province [47] 0 0
Thabazimbi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ardea Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris Storgard, MD
Address 0 0
Ardea Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01508702