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    Clinical Trial Results:
    Allopurinol in the prevention of superficial bladder tumour recurrence

    Summary
    EudraCT number
    		 2005-003219-66
    Trial protocol
    		 GB  
    Global end of trial date
    06 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2020
    First version publication date
    26 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EDGE ID 34160
    Additional study identifiers
    ISRCTN number
    		 ISRCTN65811336
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals of Leicester NHS Trust
    Sponsor organisation address
    Infirmary Square, Leicester, United Kingdom, LE1 5WW
    Public contact
    Mr L Griffiths, University Hospitals of Leicester NHS Trust, trlg1@le.ac.uk
    Scientific contact
    Mr L Griffiths, University Hospitals of Leicester NHS Trust, trlg1@le.ac.uk
    Sponsor organisation name
    University Hospitals of Leicester NHS Trust
    Sponsor organisation address
    Infirmary Square. Infirmary Road, Leicester, United Kingdom, LE1 5WW
    Public contact
    Mr Griffiths, University Hospitals of Leicester NHS Trust, trlg1@le.ac.uk
    Scientific contact
    Mr Griffiths, University Hospitals of Leicester NHS Trust, trlg1@le.ac.uk
    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
    06 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Patients with superficial bladder cancer, at intermediate and high risk of recurrence could benefit from an oral medication(allopurinol) used in a cancer prevention role, and thereby reduce the need for repeated hospital admissions for surgery to remove the bladder tumour (TURBT) and invasive check-up procedures(Cystoscopy). This would not only have financial benefits to the health service but also reduce patient anxiety.
    Protection of trial subjects
    Ethics favourable opinion will be obtained from an appropriate committee. The Trust R&D approval is mandatory
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Sep 2006
    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
    United Kingdom: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    0
    From 65 to 84 years
    17
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 The aim is to recruit 64 patients 32 to receive allopurinol and 32 to receive placebo Randomisation procedure The pharmacy department at Leicester General Hospital will randomise patients once allocated to Group A, B or C.

    Pre-assignment
    Screening details
    		 First superficial TCC bladder cancer diagnosis within 12 months Patients with solitary TCC Ta or T1 bladder tumour (Grade 1 or 2) that recurs at 3 months OR Patients with multifocal TCC Ta bladder tumours (Grade 1 or 2) that do not recur at 3 months OR Patients with multifocal TCC Ta bladder tumours (Grade 1 or 2) that recur at 3 months.

    Pre-assignment period milestones
    Number of subjects started
    		 24
    Number of subjects completed
    		 24

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ARM 1
    Arm description
    		 Allopurinol
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allopurinol (Zyloric)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg tablet by oral administration daily

    Arm title
    		 Arm 2
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo - Lactose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet daily

    Number of subjects in period 1
    		ARM 1 Arm 2
    Started
    12
    12
    Completed
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomisation
    Reporting group description
    		 -

    Reporting group values
    		 Randomisation Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 17 17
        85 years and over
    		 7 7
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 17 17
    Subject analysis sets

    Subject analysis set title
    Recruitment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects consented that were randomised to the study

    Subject analysis sets values
    		 Recruitment
    Number of subjects
    24
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    17
        85 years and over
    7
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    7
        Male
    17

    End points

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    End points reporting groups
    Reporting group title
    ARM 1
    Reporting group description
    		 Allopurinol

    Reporting group title
    Arm 2
    Reporting group description
    		 Placebo

    Subject analysis set title
    Recruitment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects consented that were randomised to the study

    Primary: Time to biopsy proven recurrence

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    End point title
    		 Time to biopsy proven recurrence [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was undertaken for this study due to insufficient recruitment
    End point values
    		 ARM 1 Arm 2
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Days
        number (not applicable)
    Notes
    [2] - Insufficient numbers for analysis
    [3] - insufficient numbers for analysis
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12 months
    Adverse event reporting additional description
    Adverse events were not collected for this study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    ARM 1
    Reporting group description
    		 Experimental

    Reporting group title
    ARM 2
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: non serious adverse events were not collected for this study
    Serious adverse events
    		 ARM 1 ARM 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Post procedural haematuria
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Inferior ST elevated myocardia infarct Inferior STEMI
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Transurethral prostatectomy
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Bilateral epididymo orchitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ARM 1 ARM 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    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.

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