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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects with Tophaceous Gout

    Summary
    EudraCT number
    		 2011-003768-55
    Trial protocol
    		 PL   ES  
    Global end of trial date
    17 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Dec 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RDEA594-304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ardea Biosciences, Inc.
    Sponsor organisation address
    9390 Towne Centre Dr, San Diego, United States, 92121
    Public contact
    Maple Fung, MD, Ardea Biosciences, Inc., US 858-652-6721, mfung@ardeabio.com
    Scientific contact
    Maple Fung, MD, Ardea Biosciences, Inc., US 858-652-6721, mfung@ardeabio.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of lesinurad by Month 6 when used in combination with febuxostat compared to febuxostat monotherapy
    Protection of trial subjects
    This study was conducted in accordance with the protocol, International Conference on Harmonisation (ICH) E6 Good Clinical Practice (GCP), the Declaration of Helsinki (2008), and all other applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 244
    Country: Number of subjects enrolled
    Canada: 17
    Country: Number of subjects enrolled
    Poland: 32
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    New Zealand: 13
    Country: Number of subjects enrolled
    Australia: 16
    Worldwide total number of subjects
    324
    EEA total number of subjects
    32
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    268
    From 65 to 84 years
    56
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening procedures to determine subject eligibility were performed within approximately 35 days prior to Day 1.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 lesinurad 200 mg + febuxostat
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    lesinurad
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg

    Arm title
    		 lesinurad 400 mg + febuxostat
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    lesinurad
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg

    Arm title
    		 Placebo + febuxostat
    Arm description
    		 -
    Arm type
    		 Placebo Comparator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		lesinurad 200 mg + febuxostat lesinurad 400 mg + febuxostat Placebo + febuxostat
    Started
    106
    109
    109
    Completed
    79
    84
    87
    Not completed
    27
    25
    22
         Adverse event, serious fatal
    1
    1
    -
         Consent withdrawn by subject
    3
    4
    3
         Adverse event, non-fatal
    7
    6
    4
         Lost to follow-up
    5
    1
    5
         Gout Flare
    -
    3
    1
         Protocol deviation
    11
    10
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    lesinurad 200 mg + febuxostat
    Reporting group description
    		 -

    Reporting group title
    lesinurad 400 mg + febuxostat
    Reporting group description
    		 -

    Reporting group title
    Placebo + febuxostat
    Reporting group description
    		 -

    Reporting group values
    		 lesinurad 200 mg + febuxostat lesinurad 400 mg + febuxostat Placebo + febuxostat Total
    Number of subjects
    		 106 109 109 324
    Age categorical
    Units: Subjects
        <65
    		 89 90 89 268
        >=65
    		 17 19 20 56
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 54.2 ( 11 ) 53.3 ( 11.2 ) 54.6 ( 10.9 ) -
    Gender, Male/Female
    Units: Participants
        Male
    		 100 102 107 309
        Female
    		 6 7 2 15
    Region of Enrollment
    Units: Subjects
        Australia
    		 6 6 4 16
        Canada
    		 9 2 6 17
        New Zealand
    		 2 6 5 13
        Poland
    		 8 10 14 32
        Switzerland
    		 0 1 1 2
        United States
    		 81 84 79 244

    End points

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    End points reporting groups
    Reporting group title
    lesinurad 200 mg + febuxostat
    Reporting group description
    		 -

    Reporting group title
    lesinurad 400 mg + febuxostat
    Reporting group description
    		 -

    Reporting group title
    Placebo + febuxostat
    Reporting group description
    		 -

    Primary: Number of subjects with an sUA level that is < 5.0 mg/dL

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    End point title
    		 Number of subjects with an sUA level that is < 5.0 mg/dL
    End point description
    End point type
    Primary
    End point timeframe
    6 months, analysis after all subjects complete 12 months
    End point values
    		 lesinurad 200 mg + febuxostat lesinurad 400 mg + febuxostat Placebo + febuxostat
    Number of subjects analysed
    106
    109
    109
    Units: Number of Subjects
    60
    83
    51
    Statistical analysis title
    		 sUA level that is < 5.0 mg/dL
    Comparison groups
    lesinurad 200 mg + febuxostat v Placebo + febuxostat
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.1298
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.23
    Statistical analysis title
    		 sUA level that is < 5.0 mg/dL
    Comparison groups
    lesinurad 400 mg + febuxostat v Placebo + febuxostat
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 0.42

    Secondary: Complete Resolution of at Least One Target Tophus

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    End point title
    		 Complete Resolution of at Least One Target Tophus
    End point description
    Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 lesinurad 200 mg + febuxostat lesinurad 400 mg + febuxostat Placebo + febuxostat
    Number of subjects analysed
    106
    109
    109
    Units: Subjects
        number (not applicable)
    27
    33
    23
    Statistical analysis title
    		 Complete Resolution Target Tophus
    Comparison groups
    lesinurad 200 mg + febuxostat v Placebo + febuxostat
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.4453
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.16
    Statistical analysis title
    		 Complete Resolution Target Tophus
    Comparison groups
    lesinurad 400 mg + febuxostat v Placebo + febuxostat
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.1149
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.21

    Secondary: Complete or Partial Response of at Least One Tophus

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    End point title
    		 Complete or Partial Response of at Least One Tophus
    End point description
    Proportion of subjects with a best tophus response on at least 1 target tophus of complete or partial resolution by Month 12.
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 lesinurad 200 mg + febuxostat lesinurad 400 mg + febuxostat Placebo + febuxostat
    Number of subjects analysed
    106
    109
    109
    Units: Subjects
    52
    56
    50
    Statistical analysis title
    		 Complete or Partial Response of Tophus
    Comparison groups
    lesinurad 200 mg + febuxostat v Placebo + febuxostat
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.645
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.17
    Statistical analysis title
    		 Complete or Partial Response Tophus
    Comparison groups
    lesinurad 400 mg + febuxostat v Placebo + febuxostat
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.4118
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.19

    Secondary: Quality of Life

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    End point title
    		 Quality of Life
    End point description
    Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 lesinurad 200 mg + febuxostat lesinurad 400 mg + febuxostat Placebo + febuxostat
    Number of subjects analysed
    77
    78
    82
    Units: Number of Subjects
    34
    26
    42
    Statistical analysis title
    		 Quality of Life
    Comparison groups
    lesinurad 200 mg + febuxostat v Placebo + febuxostat
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.3034
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.07
    Statistical analysis title
    		 Quality of Life
    Comparison groups
    lesinurad 400 mg + febuxostat v Placebo + febuxostat
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.021
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.34
         upper limit
    		 -0.04

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed from the time the subject provided informed consent through the duration of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    lesinurad 200 mg + febuxostat
    Reporting group description
    		 -

    Reporting group title
    Placebo + febuxostat
    Reporting group description
    		 -

    Reporting group title
    lesinurad 400 mg + febuxostat
    Reporting group description
    		 -

    Serious adverse events
    		 lesinurad 200 mg + febuxostat Placebo + febuxostat lesinurad 400 mg + febuxostat
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 106 (5.66%)
    10 / 109 (9.17%)
    9 / 109 (8.26%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 109 (0.00%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 109 (0.00%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 109 (0.00%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 109 (0.00%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure chronic
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Joint contracture
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 109 (0.00%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.02%
    Non-serious adverse events
    		 lesinurad 200 mg + febuxostat Placebo + febuxostat lesinurad 400 mg + febuxostat
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 106 (47.17%)
    34 / 109 (31.19%)
    59 / 109 (54.13%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    6 / 106 (5.66%)
    3 / 109 (2.75%)
    4 / 109 (3.67%)
         occurrences all number
    8
    3
    4
    Blood creatinine increased
         subjects affected / exposed
    7 / 106 (6.60%)
    3 / 109 (2.75%)
    8 / 109 (7.34%)
         occurrences all number
    7
    3
    11
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 106 (1.89%)
    3 / 109 (2.75%)
    7 / 109 (6.42%)
         occurrences all number
    2
    3
    9
    Excoriation
         subjects affected / exposed
    3 / 106 (2.83%)
    0 / 109 (0.00%)
    2 / 109 (1.83%)
         occurrences all number
    3
    0
    2
    Joint sprain
         subjects affected / exposed
    4 / 106 (3.77%)
    2 / 109 (1.83%)
    6 / 109 (5.50%)
         occurrences all number
    4
    2
    6
    Laceration
         subjects affected / exposed
    3 / 106 (2.83%)
    4 / 109 (3.67%)
    8 / 109 (7.34%)
         occurrences all number
    3
    5
    12
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 106 (5.66%)
    8 / 109 (7.34%)
    12 / 109 (11.01%)
         occurrences all number
    6
    8
    13
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 106 (9.43%)
    8 / 109 (7.34%)
    6 / 109 (5.50%)
         occurrences all number
    11
    12
    7
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 109 (0.00%)
    3 / 109 (2.75%)
         occurrences all number
    1
    0
    4
    Pyrexia
         subjects affected / exposed
    1 / 106 (0.94%)
    4 / 109 (3.67%)
    7 / 109 (6.42%)
         occurrences all number
    1
    4
    7
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 109 (0.00%)
    3 / 109 (2.75%)
         occurrences all number
    0
    0
    3
    Toothache
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 109 (0.00%)
    3 / 109 (2.75%)
         occurrences all number
    1
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 106 (3.77%)
    3 / 109 (2.75%)
    9 / 109 (8.26%)
         occurrences all number
    4
    3
    9
    Sinus congestion
         subjects affected / exposed
    4 / 106 (3.77%)
    0 / 109 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    4
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    8 / 106 (7.55%)
    5 / 109 (4.59%)
    6 / 109 (5.50%)
         occurrences all number
    9
    6
    7
    Pain in extremity
         subjects affected / exposed
    6 / 106 (5.66%)
    4 / 109 (3.67%)
    9 / 109 (8.26%)
         occurrences all number
    9
    4
    9
    Infections and infestations
    Influenza
         subjects affected / exposed
    6 / 106 (5.66%)
    2 / 109 (1.83%)
    2 / 109 (1.83%)
         occurrences all number
    6
    2
    4
    Nasopharyngitis
         subjects affected / exposed
    10 / 106 (9.43%)
    9 / 109 (8.26%)
    15 / 109 (13.76%)
         occurrences all number
    10
    12
    15
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    4 / 106 (3.77%)
    1 / 109 (0.92%)
    1 / 109 (0.92%)
         occurrences all number
    4
    1
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2011
    This amendment clarified the dosing recommendations for febuxostat when the dose has been interrupted due to potential toxicity.
    20 Jul 2012
    This amendment addressed comments received from the US FDA and reduced the complexity of the screening serum urate eligibility criteria.
    14 Jun 2013
    This amendment expanded the guidance on subject hydration and expanded the management algorithm if a subject experiences an elevated serum creatinine or kidney stone.
    02 Jan 2014
    This amendment clarified the risks associated with lesinurad in the monotherapy setting and emphasized the requirement for subjects to concomitantly take lesinurad with a xanthine oxidase inhibitor.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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