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    Clinical Trial Results:
    12-week, Multicenter, Open-label, Non-comparative Study to Investigate Pharmacodynamic and Safety of Alfuzosin 0.2 mg/kg/Day in the Treatment of Children and Adolescents 2 - 16 Years of Age With Hydronephrosis Associated With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-week Open-label Extension

    Summary
    EudraCT number
    		 2007-000983-26
    Trial protocol
    		 PL   EE   BG   SK   ES  
    Global end of trial date
    09 Oct 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Apr 2016
    First version publication date
    06 Dec 2014
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Minor correction to non-serious adverse events data (number of occurrences)

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC6269
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00576823
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & developpement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & developpement, Contact-US@sanofi.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Nov 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure (LPP) of neuropathic etiology.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 Subjects continued their standard treatment including clean intermittent catheterization and anticholinergic/antimuscarinic agents. Antibiotics, over the counter analgesics, vitamins, dietary measures and/or laxatives were permitted if indicated.
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    06 Mar 2008
    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
    Slovakia: 2
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    Malaysia: 1
    Country: Number of subjects enrolled
    Singapore: 1
    Country: Number of subjects enrolled
    Turkey: 1
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    India: 3
    Worldwide total number of subjects
    25
    EEA total number of subjects
    10
    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)
    21
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 19 sites in 12 countries. A total of 43 subjects were screened between December 2007 and September 2008.

    Pre-assignment
    Screening details
    		 18/43 screened subjects were not included: Inclusion/Exclusion criteria not respected (16), Subject's request (1), Other (2). Subjects could have several reasons for not being included. Eligible subjects received alfuzosin 0.2 mg/kg/day. Formulation/frequency assigned by Interactive Voice Response System as per age group,ability to swallow tablet.

    Period 1
    Period 1 title
    12-week Efficacy Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Alfuzosin Solution 12 weeks - 2-7 Years
    Arm description
    		 Alfuzosin solution for 12 weeks to children 2-7 years of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alfuzosin
    Investigational medicinal product code
    SL770499
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Alfuzosin solution 0.066 milligram per kilogram (mg/kg) three times daily (0.2 mg/kg/Day) administered orally for 12 weeks.

    Arm title
    		 Alfuzosin Solution 12 weeks - 8-16 Years
    Arm description
    		 Alfuzosin solution 12 weeks to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight less than (<) 30 kilogram (kg).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alfuzosin
    Investigational medicinal product code
    SL770499
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Alfuzosin solution 0.066 mg/kg three times daily (0.2 mg/kg/Day) administered orally for 12 weeks.

    Arm title
    		 Alfuzosin Tablet 12 weeks - 8-16 Years
    Arm description
    		 Alfuzosin tablet for 12 weeks to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight greater than or equal to (>=) 30 kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alfuzosin
    Investigational medicinal product code
    SL770499
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Alfuzosin tablet 0.1 mg/kg two times daily (0.2 mg/kg/Day) administered for 12 weeks.

    Number of subjects in period 1
    		Alfuzosin Solution 12 weeks - 2-7 Years Alfuzosin Solution 12 weeks - 8-16 Years Alfuzosin Tablet 12 weeks - 8-16 Years
    Started
    12
    6
    7
    Completed
    11
    6
    7
    Not completed
    1
    0
    0
         Parent's schedule issue
    1
    -
    -
    Period 2
    Period 2 title
    40-week Safety Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Alfuzosin Solution 40 weeks - 2-7 Years
    Arm description
    		 Alfuzosin solution for additional 40 weeks to children 2-7 years of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alfuzosin
    Investigational medicinal product code
    SL770499
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Alfuzosin solution 0.066 mg/kg three times daily (0.2 mg/kg/Day) administered orally for 40 weeks.

    Arm title
    		 Alfuzosin Solution 40 weeks - 8-16 Years
    Arm description
    		 Alfuzosin solution for additional 40 weeks to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight <30 kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alfuzosin
    Investigational medicinal product code
    SL770499
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Alfuzosin solution 0.066 mg/kg three times daily (0.2 mg/kg/Day) administered orally for 40 weeks.

    Arm title
    		 Alfuzosin Tablet - 8-16 Years - 40 weeks
    Arm description
    		 Alfuzosin tablet for additional 40 weeks to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight >=30 kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alfuzosin
    Investigational medicinal product code
    SL770499
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Alfuzosin tablet 0.1 mg/kg two times daily (0.2 mg/kg/Day) administered for 40 weeks.

    Number of subjects in period 2 [1]
    		Alfuzosin Solution 40 weeks - 2-7 Years Alfuzosin Solution 40 weeks - 8-16 Years Alfuzosin Tablet - 8-16 Years - 40 weeks
    Started
    11
    6
    6
    Completed
    10
    6
    6
    Not completed
    1
    0
    0
         Lack of efficacy
    1
    -
    -
    Notes
    [1] - 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: One subject in the Alfuzosin Tablet 12 weeks - 8-16 Years arm refused to continue in the extension phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Alfuzosin Solution 12 weeks - 2-7 Years
    Reporting group description
    		 Alfuzosin solution for 12 weeks to children 2-7 years of age.

    Reporting group title
    Alfuzosin Solution 12 weeks - 8-16 Years
    Reporting group description
    		 Alfuzosin solution 12 weeks to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight less than (<) 30 kilogram (kg).

    Reporting group title
    Alfuzosin Tablet 12 weeks - 8-16 Years
    Reporting group description
    		 Alfuzosin tablet for 12 weeks to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight greater than or equal to (>=) 30 kg.

    Reporting group values
    		 Alfuzosin Solution 12 weeks - 2-7 Years Alfuzosin Solution 12 weeks - 8-16 Years Alfuzosin Tablet 12 weeks - 8-16 Years Total
    Number of subjects
    		 12 6 7 25
    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
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 4.3 ± 1.5 10 ± 1.7 11.2 ± 2.3 -
    Gender categorical
    Units: Subjects
        Female
    		 7 4 5 16
        Male
    		 5 2 2 9
    Type of hydronephrosis
    Units: Subjects
        Bilateral hydronephrosis (both kidneys affected)
    		 11 4 5 20
        Unilateral hydronephrosis (one kidney affected)
    		 1 2 2 5
    Urinary Tract Infection (UTI) history within the last 3 months
    Units: Subjects
        No UTI episode
    		 9 4 6 19
        One UTI episode
    		 2 2 1 5
        Two UTI episodes
    		 1 0 0 1
    Grade of hydronephrosis - Left kidney
    Hydronephrosis was investigated by ultrasound of the kidneys, and graded using the Society of Fetal Urology (SFU) classification (5-point ordinal scale grading hydronephrosis from 0 [No hydronephrosis] to 4 [worst condition]).
    Units: grade
        median (full range (min-max))
    		 2 (1 to 3) 1.5 (1 to 3) 2 (1 to 3) -
    Grade of hydronephrosis - Right kidney
    Units: grade
        median (full range (min-max))
    		 1 (0 to 3) 2 (0 to 3) 1 (0 to 3) -
    Duration of diagnosis for hydronephrosis
    Units: years
        arithmetic mean (standard deviation)
    		 1.83 ± 2.3 5.45 ± 4.2 3.35 ± 3.05 -

    End points

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    End points reporting groups
    Reporting group title
    Alfuzosin Solution 12 weeks - 2-7 Years
    Reporting group description
    		 Alfuzosin solution for 12 weeks to children 2-7 years of age.

    Reporting group title
    Alfuzosin Solution 12 weeks - 8-16 Years
    Reporting group description
    		 Alfuzosin solution 12 weeks to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight less than (<) 30 kilogram (kg).

    Reporting group title
    Alfuzosin Tablet 12 weeks - 8-16 Years
    Reporting group description
    		 Alfuzosin tablet for 12 weeks to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight greater than or equal to (>=) 30 kg.
    Reporting group title
    Alfuzosin Solution 40 weeks - 2-7 Years
    Reporting group description
    		 Alfuzosin solution for additional 40 weeks to children 2-7 years of age.

    Reporting group title
    Alfuzosin Solution 40 weeks - 8-16 Years
    Reporting group description
    		 Alfuzosin solution for additional 40 weeks to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight <30 kg.

    Reporting group title
    Alfuzosin Tablet - 8-16 Years - 40 weeks
    Reporting group description
    		 Alfuzosin tablet for additional 40 weeks to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight >=30 kg.

    Subject analysis set title
    2-7 Years Subjects Exposed to Alfuzosin Solution
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects, 2-7 years of age, who received at least one dose of Alfuzosin 0.2 mg/kg/Day during the overall study period (efficacy phase and/or safety extension phase) regardless of the amount of treatment received.

    Subject analysis set title
    8-16 Years Subjects Exposed to Alfuzosin Solution
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects, 8-16 years of age, who received at least one dose of Alfuzosin solution 0.2 mg/kg/Day during the overall study period (efficacy phase and/or safety extension phase) regardless of the amount of treatment received.

    Subject analysis set title
    8-16 Years Subjects Exposed to Alfuzosin Tablet
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects, 8-16 years of age, who received at least one dose of Alfuzosin tablet 0.2 mg/kg/Day during the overall study period (efficacy phase and/or safety extension phase) regardless of the amount of treatment received.

    Primary: Number of Subjects With a Decrease From Baseline >= 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis

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    End point title
    		 Number of Subjects With a Decrease From Baseline >= 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis [1]
    End point description
    Hydronephrosis was investigated by ultrasound and graded using SFU classification at each time point. 'Complete response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline >=1 for both kidneys, or, unilateral hydronephrosis at baseline and grade decrease from baseline >=1 for the affected kidney without worsening of the other kidney. 'Partial response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline >=1 for one kidney without worsening of the other kidney. The analysis was performed on the intent-to-treat (ITT) population (that is, all included subjects who received at least one dose of Alfuzosin) excluding the subjects who didn't have baseline SFU grade. Subjects without post-baseline SFU grade before Week 12 were included as non-responders.
    End point type
    Primary
    End point timeframe
    baseline and 12 weeks (efficacy study phase)
    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: This was an exploratory, open label, non-comparative trial. Analysis were purely descriptive.
    End point values
    		 Alfuzosin Solution 12 weeks - 2-7 Years Alfuzosin Solution 12 weeks - 8-16 Years Alfuzosin Tablet 12 weeks - 8-16 Years
    Number of subjects analysed
    12
    6
    7
    Units: subjects
        Complete response
    2
    5
    3
        - Bilateral hydronephrosis
    1
    3
    1
        - Unilateral hydronephrosis
    1
    2
    2
        Partial response
    3
    0
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With Symptomatic Urinary Tract Infection (UTI) Episodes

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    End point title
    		 Number of Subjects With Symptomatic Urinary Tract Infection (UTI) Episodes
    End point description
    When a subject presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture. A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism. The analysis was performed on the ITT population (that is, all included subjects who received at least one dose of Alfuzosin).
    End point type
    Secondary
    End point timeframe
    12 weeks (efficacy study phase)
    End point values
    		 Alfuzosin Solution 12 weeks - 2-7 Years Alfuzosin Solution 12 weeks - 8-16 Years Alfuzosin Tablet 12 weeks - 8-16 Years
    Number of subjects analysed
    12
    6
    7
    Units: subject
        No symptomatic UTI
    11
    5
    7
        One symptomatic UTI
    0
    1
    0
        Two symptomatic UTI
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Symptomatic Urinary Tract Infection (UTI) Episodes

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    End point title
    		 Number of Subjects With Symptomatic Urinary Tract Infection (UTI) Episodes
    End point description
    The analysis was performed on the exposed population (that is, all subjects who received at least one dose of Alfuzosin regardless of the amount of treatment received).
    End point type
    Secondary
    End point timeframe
    52 weeks (efficacy and extension study phases)
    End point values
    		 2-7 Years Subjects Exposed to Alfuzosin Solution 8-16 Years Subjects Exposed to Alfuzosin Solution 8-16 Years Subjects Exposed to Alfuzosin Tablet
    Number of subjects analysed
    12
    6
    7
    Units: subjects
        No symptomatic UTI
    8
    5
    5
        One symptomatic UTI
    2
    0
    2
        Two symptomatic UTI
    2
    0
    0
        Three symptomatic UTI
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (52 weeks) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Treatment-emergent AEs are reported that is AEs that developed/worsened during on treatment period (time from 1st dose of drug up to 48 h [5 half lives] after last dose of drug of 12-week efficacy phase and up to time before 1st administration of extension phase for subjects continuing in the extension or after last dose of drug [for whole study]).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Afluzosin Solution - 2-7 years
    Reporting group description
    		 All subjects, 2-7 years of age, who received at least one dose of Alfuzosin 0.2 mg/kg/Day during the overall study period (efficacy phase and/or safety extension phase) regardless of the amount of treatment received.

    Reporting group title
    Afluzosin Tablets - 8-16 years
    Reporting group description
    		 All subjects, 8-16 years of age, who received at least one dose of Alfuzosin tablet 0.2 mg/kg/Day during the overall study period (efficacy phase and/or safety extension phase) regardless of the amount of treatment received.

    Reporting group title
    Afluzosin Solution - 8-16 years
    Reporting group description
    		 All subjects, 8-16 years of age, who received at least one dose of Alfuzosin solution 0.2 mg/kg/Day during the overall study period (efficacy phase and/or safety extension phase) regardless of the amount of treatment received.

    Serious adverse events
    		 Afluzosin Solution - 2-7 years Afluzosin Tablets - 8-16 years Afluzosin Solution - 8-16 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Femur Fracture
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (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
    Ureteric Injury
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (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
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         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
    Cough
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus Urinary
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (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
    Renal Impairment
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (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
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (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
    Urinary Tract Infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Afluzosin Solution - 2-7 years Afluzosin Tablets - 8-16 years Afluzosin Solution - 8-16 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 12 (75.00%)
    5 / 7 (71.43%)
    5 / 6 (83.33%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Forearm Fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Iatrogenic Injury
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Limb Injury
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Urethral Injury
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Oedema Peripheral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    2
    0
    3
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Dry Mouth
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Vaginal Discharge
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory Disorder
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis Allergic
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Conjunctivitis Infective
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    5
    1
    0
    Ear Infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal Infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal Viral Infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    5
    0
    2
    Pharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    1
    Pneumonia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Pyelonephritis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    4
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    Viral Infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Viral Pharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Viral Rhinitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 May 2008
    Several aspects of original protocol were modified in order to change the grading of hydronephrosis in the inclusion criteria (Grade 3 hydronephrosis was added), to clarify the grading of the Vesicoureteral Reflux (VUR) and grading of ureteral dilatation, to better characterize the assessment of vital signs, and to modify the schedule of the collection of pharmacokinetic samples and the schedule of the ultrasound assessments.
    17 Jul 2008
    Additional ultrasound assessments were scheduled and provided further clarification on the grading of the VUR and grading of ureteral dilatation. A detailed Investigator instruction letter for VUR grading was also provided to the sites.
    06 Oct 2008
    The temporary treatment discontinuation procedure was revised and characterized the collection of laboratory results in more detail. In addition, a few minor editorial changes were made to the protocol.

    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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