Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients with Gout

    Summary
    EudraCT number
    		 2009-013055-30
    Trial protocol
    		 ES   DE   GB   CZ   BG  
    Global end of trial date
    06 Sep 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Feb 2017
    First version publication date
    05 Feb 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RDEA594-202
    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 Drive, San Diego, United States, 92121
    Public contact
    Maple Fung, MD, Ardea Biosciences, Inc., 1 8586526500 x,
    Scientific contact
    Maple Fung, MD, Ardea Biosciences, Inc., 1 8586526500 x, 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
    26 Mar 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
    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
    21 Aug 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 39
    Country: Number of subjects enrolled
    Canada: 37
    Country: Number of subjects enrolled
    Czech Republic: 10
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Poland: 27
    Country: Number of subjects enrolled
    Georgia: 15
    Country: Number of subjects enrolled
    United States: 9
    Worldwide total number of subjects
    143
    EEA total number of subjects
    82
    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)
    124
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were to be screened within 28 days prior to the first dose of study drug (Day 0) and up to 14 days before initiation of colchicine treatment.

    Period 1
    Period 1 title
    Main
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 lesinurad 200 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    lesinurad 200 mg
    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
    Arm description
    		 -
    Arm type
    		 Experimental

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

    Arm title
    		 lesinurad 600 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    lesinurad 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600 mg

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    N/A

    Number of subjects in period 1 [1]
    		lesinurad 200 mg lesinurad 400 mg lesinurad 600 mg Placebo
    Started
    31
    33
    32
    27
    Completed
    28
    27
    30
    23
    Not completed
    3
    6
    2
    4
         Consent withdrawn by subject
    3
    2
    -
    1
         N/A
    -
    1
    -
    -
         Adverse event, non-fatal
    -
    2
    -
    -
         Lost to follow-up
    -
    1
    1
    2
         Protocol deviation
    -
    -
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Subjects were withdrawn prior to dosing of study medication.
    Period 2
    Period 2 title
    Open Label Extension
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Arm title
    		 Pooled
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    lesinurad 200 mg, 400 mg, 600 mg, Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg, 400 mg, 600 mg

    Number of subjects in period 2 [2]
    		Pooled
    Started
    50
    Completed
    8
    Not completed
    42
         Discharged after study closure
    4
         Consent withdrawn by subject
    9
         N/A
    3
         Adverse event, non-fatal
    6
         Investigator Judgment
    1
         Site Closures
    14
         Lost to follow-up
    1
         Protocol deviation
    4
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects were withdrawn prior to dosing of study medication.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    lesinurad 200 mg
    Reporting group description
    		 -

    Reporting group title
    lesinurad 400 mg
    Reporting group description
    		 -

    Reporting group title
    lesinurad 600 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 lesinurad 200 mg lesinurad 400 mg lesinurad 600 mg Placebo Total
    Number of subjects
    		 31 33 32 27 123
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 28 29 27 23 107
        From 65-84 years
    		 3 4 5 4 16
        85 years and over
    		 0 0 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 51 ( 11.3 ) 52.8 ( 9.2 ) 53.4 ( 12.6 ) 49.9 ( 11.2 ) -
    Gender, Male/Female
    Units: Participants
        Male
    		 31 32 31 27 121
        Female
    		 0 1 1 0 2
    Region of Enrollment
    Units: Subjects
        Bulgaria
    		 8 10 7 8 33
        Canada
    		 6 10 12 8 36
        Czech Republic
    		 1 1 3 2 7
        Germany
    		 2 2 1 0 5
        Poland
    		 7 5 3 6 21
        Republic of Georgia
    		 3 4 4 3 14
        USA
    		 4 1 2 0 7
    Age, Customized
    Units: Subjects
        <65
    		 28 29 27 23 107
        >=65
    		 3 4 5 4 16

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    lesinurad 200 mg
    Reporting group description
    		 -

    Reporting group title
    lesinurad 400 mg
    Reporting group description
    		 -

    Reporting group title
    lesinurad 600 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Pooled
    Reporting group description
    		 -

    Primary: To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.

    		 Close Top of page
    End point title
    		 To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
    End point description
    End point type
    Primary
    End point timeframe
    28 Days
    End point values
    		 lesinurad 200 mg lesinurad 400 mg lesinurad 600 mg Placebo
    Number of subjects analysed
    26
    26
    26
    21
    Units: Number of events
        number (not applicable)
    7.7
    30.8
    38.5
    0
    Statistical analysis title
    		 Number of Subjects with sUA < 6.0 mg/dL
    Comparison groups
    lesinurad 200 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4949
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Number of Subjects with sUA < 6.0 mg/dL
    Comparison groups
    lesinurad 600 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0033
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Number of Subjects with sUA < 6.0 mg/dL
    Comparison groups
    lesinurad 400 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0112
    Method
    		 Fisher exact
    Confidence interval

    Secondary: To evaluate the proportion of subjects whose sUA levels are <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL at each weekly study visit during the Double-Blind Period.

    		 Close Top of page
    End point title
    		 To evaluate the proportion of subjects whose sUA levels are <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL at each weekly study visit during the Double-Blind Period.
    End point description
    End point type
    Secondary
    End point timeframe
    28 Days
    End point values
    		 lesinurad 200 mg lesinurad 400 mg lesinurad 600 mg Placebo
    Number of subjects analysed
    31
    33
    32
    27
    Units: Number
    number (not applicable)
        <6.0 mg/dL at Day 7
    9.7
    12.1
    13.8
    0
        <6.0 mg/dL at Day 14
    3.4
    33.3
    33.3
    4.5
        <6.0 mg/dL at Day 21
    3.8
    25.9
    46.2
    0
        <6.0 mg/dL at Day 28
    7.7
    30.8
    38.5
    0
        <5.0 mg/dL at Day 7
    0
    3
    3.4
    0
        <5.0 mg/dL at Day 14
    0
    13.3
    7.4
    0
        <5.0 mg/dL at Day 21
    0
    3.7
    23.1
    0
        <5.0 mg/dL at Day 28
    3.8
    7.7
    15.4
    0
        <4.0 mg/dL at Day 7
    0
    3
    0
    0
        <4.0 mg/dL at Day 14
    0
    0
    0
    0
        <4.0 mg/dL at Day 21
    0
    0
    7.7
    0
        <4.0 mg/dL at Day 28
    0
    0
    0
    0
    Statistical analysis title
    		 sUA levels <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL
    Comparison groups
    lesinurad 200 mg v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 sUA levels <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL
    Comparison groups
    lesinurad 600 mg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 sUA levels <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL
    Comparison groups
    lesinurad 400 mg v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit. (Main Period)

    		 Close Top of page
    End point title
    		 To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit. (Main Period)
    End point description
    Value provided by randomized treatment
    End point type
    Secondary
    End point timeframe
    Up to day 28
    End point values
    		 lesinurad 200 mg lesinurad 400 mg lesinurad 600 mg Placebo
    Number of subjects analysed
    31
    33
    32
    27
    Units: Number
    number (not applicable)
        Day 7 Absolute reduction from baseline
    -2.15
    -2.33
    -2.46
    -0.17
        Day 7 Percent reduction from baseline
    -21.88
    -22.32
    -24.33
    -0.96
        Day 14 Absolute reduction from baseline
    -1.67
    -2.61
    -3.11
    -0.15
        Day 14 Percent reduction from baseline
    -16.87
    -25.09
    -31.18
    -0.37
        Day 21 Absolute reduction from baseline
    -1.58
    -2.34
    -3.65
    -0.06
        Day 21 Percent reduction from baseline
    -15.67
    -21.96
    -36.68
    0.52
        Day 28 Absolute reduction from baseline
    -1.73
    -2.92
    -2.94
    -0.02
        Day 28 Percent reduction from baseline
    -17.7
    -28.92
    -29.11
    0.75
    Statistical analysis title
    		 Absolute and percent reduction from baseline
    Comparison groups
    lesinurad 200 mg v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.01
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Absolute and percent reduction from baseline
    Comparison groups
    lesinurad 600 mg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.01
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Absolute and percent reduction from baseline
    Comparison groups
    lesinurad 400 mg v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.01
    Method
    		 ANCOVA
    Confidence interval

    Secondary: To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.

    		 Close Top of page
    End point title
    		 To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.
    End point description
    End point type
    Secondary
    End point timeframe
    28 Days
    End point values
    		 lesinurad 200 mg lesinurad 400 mg lesinurad 600 mg Placebo
    Number of subjects analysed
    31
    33
    32
    27
    Units: Number
        number (not applicable)
    7.58
    1.79
    3.21
    -10.45
    Statistical analysis title
    		 Percentage change in 24-hour urine urate level
    Comparison groups
    lesinurad 200 mg v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4267
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Percentage change in 24-hour urine urate level
    Comparison groups
    lesinurad 400 mg v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.873
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Percentage change in 24-hour urine urate level
    Comparison groups
    lesinurad 600 mg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7872
    Method
    		 ANCOVA
    Confidence interval

    Secondary: To evaluate the incidence of gout flares. (Main Period)

    		 Close Top of page
    End point title
    		 To evaluate the incidence of gout flares. (Main Period)
    End point description
    End point type
    Secondary
    End point timeframe
    28 Days
    End point values
    		 lesinurad 200 mg lesinurad 400 mg lesinurad 600 mg Placebo
    Number of subjects analysed
    31
    33
    32
    27
    Units: Percent
        number (not applicable)
    9.7
    12.1
    12.5
    3.7
    No statistical analyses for this end point

    Secondary: To evaluate the safety and tolerability of RDEA594 in subjects with gout. (Main period)

    		 Close Top of page
    End point title
    		 To evaluate the safety and tolerability of RDEA594 in subjects with gout. (Main period)
    End point description
    End point type
    Secondary
    End point timeframe
    28 Days and through extension
    End point values
    		 lesinurad 200 mg lesinurad 400 mg lesinurad 600 mg Placebo
    Number of subjects analysed
    31
    33
    32
    27
    Units: Percent (Subjects with TEAEs)
        number (not applicable)
    25.8
    45.5
    34.4
    22.2
    No statistical analyses for this end point

    Secondary: To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL in the Open-Label Extension Period.

    		 Close Top of page
    End point title
    		 To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL in the Open-Label Extension Period.
    End point description
    End point type
    Secondary
    End point timeframe
    18 Months
    End point values
    		 Pooled
    Number of subjects analysed
    48
    Units: n/N
    number (not applicable)
        Week 2 - Extension
    19.6
        Week 4 - Extension
    10.6
        Week 6 - Extension
    12.5
        Week 8 - Extension
    26.2
        Week 10 - Extension
    50
        Week 12 - Extension
    37.5
        Week 14 - Extension
    31.6
        Week 16 - Extension
    34.3
        Week 18 - Extension
    37.5
        Week 20 - Extension
    37.1
        Week 22 - Extension
    50
        Week 28 - Extension
    77.8
        Week 36 - Extension
    50
        Week 44 - Extension
    87.5
        Week 52 - Extension
    85.7
        Week 60 - Extension
    80
        Week 68 - Extension
    100
    No statistical analyses for this end point

    Secondary: To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit. (Open-Label Extension)

    		 Close Top of page
    End point title
    		 To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit. (Open-Label Extension)
    End point description
    Value provided by maximum dose level.
    End point type
    Secondary
    End point timeframe
    28 Days and through extension
    End point values
    		 Pooled
    Number of subjects analysed
    48
    Units: Number
    number (not applicable)
        Week 2 Absolute reduction from baseline
    -1.07
        Week 2 Percent reduction from baseline
    -11.3
        Week 4 Absolute reduction from baseline
    -0.87
        Week 4 Percent reduction from baseline
    -8.47
        Week 6 Absolute reduction from baseline
    -1.31
        Week 6 Percent reduction from baseline
    -13.27
        Week 8 Absolute reduction from baseline
    -1.2
        Week 8 Percent reduction from baseline
    -12.29
        Week 10 Absolute reduction from baseline
    -1.71
        Week10 Percent reduction from baseline
    -20.75
        Week 12 Absolute reduction from baseline
    -1.39
        Week 12 Percent reduction from baseline
    -15.18
        Week 14 Absolute reduction from baseline
    -1.36
        Week 14 Percent reduction from baseline
    -15.43
        Week 16 Absolute reduction from baseline
    -1.46
        Week 16 Percent reduction from baseline
    -16.89
        Week 18 Absolute reduction from baseline
    -2.18
        Week 18 Percent reduction from baseline
    -22.33
        Week 20 Absolute reduction from baseline
    -1.67
        Week 20 Percent reduction from baseline
    -18.41
        Week 22 Absolute reduction from baseline
    -2.7
        Week 22 Percent reduction from baseline
    -31.94
        Week 28 Absolute reduction from baseline
    -2.8
        Week 28 Percent reduction from baseline
    -32.22
        Week 36 Absolute reduction from baseline
    -2.47
        Week 36 Percent reduction from baseline
    -27.96
        Week 44 Absolute reduction from baseline
    -2.49
        Week 44 Percent reduction from baseline
    -28.11
        Week 52 Absolute reduction from baseline
    -2.33
        Wee 52 Percent reduction from baseline
    -27.55
        Week 60 Absolute reduction from baseline
    -2.7
        Week 60 Percent reduction from baseline
    -32.3
        Week 68 Absolute reduction from baseline
    -2.8
        Week 68 Percent reduction from baseline
    -36.84
    No statistical analyses for this end point

    Secondary: To evaluate the incidence of gout flares. (Open-label Extension)

    		 Close Top of page
    End point title
    		 To evaluate the incidence of gout flares. (Open-label Extension)
    End point description
    End point type
    Secondary
    End point timeframe
    28 Days and through extension
    End point values
    		 Pooled
    Number of subjects analysed
    50
    Units: Gout Flare Rate (per 28 days)
    number (not applicable)
        Month 1
    0.0406
        Month 2
    0.1804
        Month 3
    0.0962
        Month 4
    0.0522
        Month 5
    0
        Month 6
    0.056
        Month 7
    0
        Month 8
    0.0996
        Month 9
    0
        Month 10
    0.1167
        Month 11
    0
        Month 12
    0.1267
        Month 13
    0.2857
        Month 14
    0
        Month 15
    0
        Month 16
    0
        Month 17
    0
    No statistical analyses for this end point

    Secondary: To evaluate the safety and tolerability of RDEA594 in subjects with gout. (Open-label extension)

    		 Close Top of page
    End point title
    		 To evaluate the safety and tolerability of RDEA594 in subjects with gout. (Open-label extension)
    End point description
    End point type
    Secondary
    End point timeframe
    28 Days and through extension
    End point values
    		 Pooled
    Number of subjects analysed
    50
    Units: Percent (Subjects with AE)
        number (not applicable)
    64
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    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
    12.0
    Reporting groups
    Reporting group title
    main period 200 mg
    Reporting group description
    		 -

    Reporting group title
    main period 600 mg
    Reporting group description
    		 -

    Reporting group title
    main period 400 mg
    Reporting group description
    		 -

    Reporting group title
    main period placebo
    Reporting group description
    		 -

    Reporting group title
    open-label extension period maximum dose 200 mg
    Reporting group description
    		 -

    Reporting group title
    open-label extension period maximum dose 400 mg
    Reporting group description
    		 -

    Reporting group title
    open-label extension period maximum dose 600 mg
    Reporting group description
    		 -

    Serious adverse events
    		 main period 200 mg main period 600 mg main period 400 mg main period placebo open-label extension period maximum dose 200 mg open-label extension period maximum dose 400 mg open-label extension period maximum dose 600 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 main period 200 mg main period 600 mg main period 400 mg main period placebo open-label extension period maximum dose 200 mg open-label extension period maximum dose 400 mg open-label extension period maximum dose 600 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 31 (25.81%)
    11 / 32 (34.38%)
    15 / 33 (45.45%)
    6 / 27 (22.22%)
    1 / 4 (25.00%)
    12 / 15 (80.00%)
    21 / 31 (67.74%)
    Vascular disorders
    Epistaxis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Flushing
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    2 / 31 (6.45%)
         occurrences all number
    1
    0
    1
    0
    0
    3
    6
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Chills
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    3
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Sensation of pressure
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Oropharyngeal pain
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    1
    0
    3
    3
    Blood creatinine increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    6
    Blood triglycerides increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    Creatinine renal clearance decreased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    6
    Lipase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Liver function test abnormal
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    Renal function test abnormal
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    2 / 15 (13.33%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    6
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Excoriation
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    6
    Muscle strain
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Periorbital haematoma
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Skin laceration
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Tendon injury
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Atrial fibrillation
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
    1 / 33 (3.03%)
    2 / 27 (7.41%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    1
    2
    0
    0
    3
    Sciatica
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Sensory disturbance
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Otitis media
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Vertigo
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    4
    Abdominal pain upper
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    1
    1
    0
    3
    3
    Abdominal tenderness
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Diarrhoea
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    6
    Dry mouth
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Dysgeusia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    2 / 33 (6.06%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Melaena
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Nausea
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    9
    Toothache
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Vomiting
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    6
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    3
    0
    Pollakiuria
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Urge incontinence
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    3
    Back pain
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 32 (6.25%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    0
    2
    0
    0
    0
    6
    4
    Bursitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    6
    Pain in extremity
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Gastroenteritis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    6
    Nasopharyngitis
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 32 (3.13%)
    3 / 33 (9.09%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    3
    2
    0
    0
    4
    Sinusitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    6
    Tooth abscess
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
    1 / 33 (3.03%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    4
    Viral infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    3 / 31 (9.68%)
    8 / 32 (25.00%)
    4 / 33 (12.12%)
    1 / 27 (3.70%)
    0 / 4 (0.00%)
    7 / 15 (46.67%)
    9 / 31 (29.03%)
         occurrences all number
    3
    10
    6
    2
    0
    22
    40
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 27 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2009
    Changes were made to the protocol to address new safety information from the US FDA about colchicine and the related concerns raised by German Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM).
    15 Dec 2009
    The protocol was primarily amended to allow for extended dosing of subjucts by adding an optional Open-Label Extension Period for subjects who successfully complete the 4-week Double-Blind Treatment Period and attend the follow-up visit.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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.

    European Medicines Agency © 1995-Fri Apr 26 07:43:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA