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    Clinical Trial Results:
    A Phase IIb/III, multi-centre, double-blind, randomised, placebo-controlled, dose ranging study of tamsulosin hydrochloride (low, medium and high dose) as treatment in children with neuropathic bladder for three months

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2006-003048-52
    Trial protocol
    DE   BE   ES   IT  
    Global end of trial date
    12 Feb 2009

    Results information
    Results version number
    v2(current)
    This version publication date
    02 Jul 2016
    First version publication date
    09 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT- Results

    Trial information

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    Trial identification
    Sponsor protocol code
    527.51
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00796614
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    173 Binger Strasse, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim , +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim , +1 8002430127, clintriage.rdg@boehringer-ingelheim.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?
    Yes
    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
    12 Mar 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Feb 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit (e.g., spina bifida). This trial consisted two study periods: Study Period I, double-blind, dose titration period of 2 weeks. Study Period II, a double-blind maintenance treatment period of 3 months. In Period II, all patients completing the titration phase entered the 12-week maintenance treatment phase on their randomised dose. The patients stayed on this dose for the duration of the trial.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Nov 2007
    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
    Spain: 2
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    India: 83
    Country: Number of subjects enrolled
    United States: 13
    Country: Number of subjects enrolled
    Mexico: 20
    Country: Number of subjects enrolled
    Brazil: 7
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 23
    Country: Number of subjects enrolled
    Philippines: 27
    Country: Number of subjects enrolled
    Ukraine: 13
    Country: Number of subjects enrolled
    South Africa: 16
    Worldwide total number of subjects
    231
    EEA total number of subjects
    16
    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)
    168
    Adolescents (12-17 years)
    63
    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
    The trial included children from 2-16 years of age,with elevated LPP associated with a known neurologic defect(e.g., spina bifida).The 3 age strata were 2-<5 years,5-<10 years &10-16 years of age.A "Missing" category is unavailable for age group breakdown of enrolled subjects.Hence,1 subject with a missing data is added to age-category"12-17 years.

    Pre-assignment
    Screening details
    All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they met all implemented inclusion/exclusion criteria. Subjects were not randomised to trial drug if any of the specific entry criteria was violated. In this study,231 subjects enrolled,162 subjects randomised &161 subjects treated.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    This trial was double blinded and to maintain the double-blind design, study medications were supplied so that the tamsulosin hydrochloride and placebo capsules were identical.The contents of each placebo capsule had an identical volume to the corresponding capsule of the same dose level of active medication.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo (tamsulosin hydrochloride)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Arm title
    tamsulosin - low dose level
    Arm description
    Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.025 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered to low dose (0.025 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg – 25.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.05 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered to low dose (0.05 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (25.1 kg – 50.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered to low dose (0.1 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (50.1 kg – 100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Arm title
    tamsulosin - medium dose level
    Arm description
    Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. One subject randomised to tamsulosin - medium dose level was not treated. Although actual number of subjects started is 40, 39 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.05 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered to medium dose (0.05 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg – 25.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered to medium dose (0.1 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (25.1 kg – 50.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.2 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered to medium dose (0.2 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (50.1 kg – 100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Arm title
    tamsulosin - high dose level
    Arm description
    Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered to high dose (0.1) mg of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg – 25.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.2 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered to high dose (0.2 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (25.1 kg– 50.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.4 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered to high dose (0.4 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (50.1 kg– 100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Number of subjects in period 1 [1]
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Started
    41
    40
    39
    41
    Completed
    36
    36
    36
    40
    Not completed
    5
    4
    3
    1
         Protocol deviation
    -
    -
    2
    -
         Adverse event, non-fatal
    1
    2
    -
    -
         Other than stated
    1
    -
    -
    -
         Consent withdrawn by subject
    1
    -
    -
    1
         Lost to follow-up
    2
    2
    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: Baseline characteristics are based on the patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Reporting group title
    tamsulosin - low dose level
    Reporting group description
    Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Reporting group title
    tamsulosin - medium dose level
    Reporting group description
    Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. One subject randomised to tamsulosin - medium dose level was not treated. Although actual number of subjects started is 40, 39 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group title
    tamsulosin - high dose level
    Reporting group description
    Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Reporting group values
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level Total
    Number of subjects
    41 40 39 41 161
    Age categorical
    Units: Subjects
        2 to < 5 years
    7 8 7 8 30
        5 to < 10 years
    18 17 17 18 70
        10 to 16 years
    16 15 15 15 61
    Age continuous
    Treated set was used for this Study. Treated Set (TS): Includes all patients who were documented to have taken at least one dose of randomised treatment.
    Units: years
        arithmetic mean (standard deviation)
    8.4 ± 3.7 8.1 ± 4.2 8.1 ± 3.8 8.2 ± 4.3 -
    Gender categorical
    Units: Subjects
        Female
    16 18 14 16 64
        Male
    25 22 25 25 97

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Reporting group title
    tamsulosin - low dose level
    Reporting group description
    Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Reporting group title
    tamsulosin - medium dose level
    Reporting group description
    Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. One subject randomised to tamsulosin - medium dose level was not treated. Although actual number of subjects started is 40, 39 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group title
    tamsulosin - high dose level
    Reporting group description
    Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Primary: Response defined as patients who decrease their detrusor leak point pressure (LPP) to <40 cm H2O based upon two evaluations on the same day.

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    End point title
    Response defined as patients who decrease their detrusor leak point pressure (LPP) to <40 cm H2O based upon two evaluations on the same day.
    End point description
    The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. Full analysis set-LPP (FAS-LPP): Includes all patients in the treated set who received at least one dose of randomised. FAS-LPP contains same patients as TS. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.
    End point type
    Primary
    End point timeframe
    Week 14
    End point values
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Number of subjects analysed
    34 [1]
    35 [2]
    33 [3]
    33 [4]
    Units: Percentage of participants
        number (not applicable)
    35.3
    45.7
    27.3
    42.4
    Notes
    [1] - Full analysis set-LPP (FAS-LPP), OT
    [2] - Full analysis set-LPP (FAS-LPP), OT
    [3] - Full analysis set-LPP (FAS-LPP), OT
    [4] - Full analysis set-LPP (FAS-LPP), OT
    Statistical analysis title
    tamsulosin - low dose vs. Placebo
    Statistical analysis description
    Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - low dose level v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5388
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    3.8
    Statistical analysis title
    tamsulosin - medium dose vs. Placebo
    Statistical analysis description
    Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region.The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - medium dose level v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.343
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.2
         upper limit
    1.76
    Statistical analysis title
    tamsulosin - high dose vs. Placebo
    Statistical analysis description
    Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - high dose level v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5209
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    3.97
    Statistical analysis title
    Test of Trend
    Statistical analysis description
    A test of trend across the four treatment groups was performed as a secondary analysis in the proportion of responders across the dose levels using Cochran−Armitage trend test.
    Comparison groups
    Placebo v tamsulosin - low dose level v tamsulosin - medium dose level v tamsulosin - high dose level
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9436
    Method
    Cochran−Armitage trend test
    Confidence interval

    Secondary: Change from baseline in LPP at Week 14 (end of treatment)

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    End point title
    Change from baseline in LPP at Week 14 (end of treatment)
    End point description
    Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14
    End point values
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Number of subjects analysed
    30 [5]
    32 [6]
    31 [7]
    33 [8]
    Units: cm H2O
        least squares mean (standard error)
    -11.4 ± 4.6
    -17.6 ± 4.5
    -4.6 ± 4.4
    -14.3 ± 4.3
    Notes
    [5] - Full analysis set-LPP(FAS-LPP), OT
    [6] - Full analysis set-LPP(FAS-LPP), OT
    [7] - Full analysis set-LPP(FAS-LPP), OT
    [8] - Full analysis set-LPP(FAS-LPP), OT
    Statistical analysis title
    tamsulosin - low dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - low dose level v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3097
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -18.22
         upper limit
    5.83
    Statistical analysis title
    tamsulosin - medium dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - medium dose level v Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2676
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.28
         upper limit
    18.85
    Statistical analysis title
    tamsulosin - high dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - high dose level v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6265
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.84
         upper limit
    8.98

    Secondary: Percentage Change from baseline in LPP at Week 14 (end of treatment)

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    End point title
    Percentage Change from baseline in LPP at Week 14 (end of treatment)
    End point description
    Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14.
    End point values
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Number of subjects analysed
    30 [9]
    32 [10]
    31 [11]
    33 [12]
    Units: Percentage change
        least squares mean (standard error)
    -19.9 ± 7.3
    -27.4 ± 7.1
    -1.9 ± 7
    -23.9 ± 6.9
    Notes
    [9] - Full analysis set-LPP(FAS-LPP), OT
    [10] - Full analysis set-LPP(FAS-LPP), OT
    [11] - Full analysis set-LPP(FAS-LPP), OT
    [12] - Full analysis set-LPP(FAS-LPP), OT
    Statistical analysis title
    tamsulosin - low dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - low dose level v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4359
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -26.68
         upper limit
    11.58
    Statistical analysis title
    tamsulosin - medium dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - medium dose level v Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0658
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.19
         upper limit
    37.17
    Statistical analysis title
    tamsulosin - high dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - high dose level v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6709
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -23.01
         upper limit
    14.87

    Secondary: Response defined as improvement or stabilisation of hydronephrosis based upon the renal ultrasound grading at Week 14 (end of treatment) compared to baseline

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    End point title
    Response defined as improvement or stabilisation of hydronephrosis based upon the renal ultrasound grading at Week 14 (end of treatment) compared to baseline
    End point description
    Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading. The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization. The Full analysis set-renal (FAS-RENAL): Includes all patients in the treated set who received at least one dose of randomised treatment and had at least one on-treatment renal ultrasound measurement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14.
    End point values
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Number of subjects analysed
    40 [13]
    38 [14]
    38 [15]
    40 [16]
    Units: Participants
        Left Kidney (N= 34, 34, 33, 40)
    32
    31
    31
    37
        Right Kidney (N= 33, 34, 34, 40)
    31
    33
    30
    38
    Notes
    [13] - Full analysis set-renal (FAS-RENAL), OT
    [14] - Full analysis set-renal (FAS-RENAL), OT
    [15] - Full analysis set-renal (FAS-RENAL), OT
    [16] - Full analysis set-renal (FAS-RENAL), OT
    Statistical analysis title
    tamsulosin - low dose vs. Placebo(Left Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-low dose (LD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 63 (31 for tamsulosin-LD & 32 for placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
    Comparison groups
    tamsulosin - low dose level v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5672
    Method
    Regression, Logistic
    Confidence interval
    Statistical analysis title
    tamsulosin - medium dose vs. Placebo (Left Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-medium dose (MD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 63 (31 in tamsulosin-MD & 32 in placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
    Comparison groups
    tamsulosin - medium dose level v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8724
    Method
    Regression, Logistic
    Confidence interval
    Statistical analysis title
    tamsulosin - high dose vs. Placebo (Left Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-high dose (HD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 69 (37 in tamsulosin-HD & 32 in placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (80) does not reflect the actual number.
    Comparison groups
    tamsulosin - high dose level v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7674
    Method
    Regression, Logistic
    Confidence interval
    Statistical analysis title
    tamsulosin-low dose vs. Placebo (Right Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-low dose (LD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 64 (33 for tamsulosin-LD & 31 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
    Comparison groups
    tamsulosin - low dose level v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5545
    Method
    Regression, Logistic
    Confidence interval
    Statistical analysis title
    tamsulosin-medium dose vs. Placebo (Right Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-Medium dose (MD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 61(30 for tamsulosin-MD & 31 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
    Comparison groups
    tamsulosin - medium dose level v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4774
    Method
    Regression, Logistic
    Confidence interval
    Statistical analysis title
    tamsulosin-high dose vs. Placebo (Right Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-High dose (HD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use,and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 69 (38 for tamsulosin-HD & 31 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (80) does not reflect the actual number.
    Comparison groups
    tamsulosin - high dose level v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8626
    Method
    Regression, Logistic
    Confidence interval

    Secondary: Response defined as improvement or stabilisation of hydroureter based upon the renal ultrasound at Week 14 (end of treatment) compared to baseline

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    End point title
    Response defined as improvement or stabilisation of hydroureter based upon the renal ultrasound at Week 14 (end of treatment) compared to baseline
    End point description
    Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14). Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14
    End point values
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Number of subjects analysed
    40 [17]
    38 [18]
    38 [19]
    40 [20]
    Units: Participants
        Left Kidney (N= 34, 34, 33, 40)
    33
    33
    32
    38
        Right Kidney (N= 33, 34, 34, 40)
    33
    33
    32
    38
    Notes
    [17] - Full analysis set-renal (FAS-RENAL), OT
    [18] - Full analysis set-renal (FAS-RENAL), OT
    [19] - Full analysis set-renal (FAS-RENAL), OT
    [20] - Full analysis set-renal (FAS-RENAL), OT
    Statistical analysis title
    tamsulosin - low dose vs. Placebo (Left Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-low dose (LD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 66 (33 for tamsulosin-LD & 33 for placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
    Comparison groups
    tamsulosin - low dose level v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9669
    Method
    Regression, Logistic
    Confidence interval
    Statistical analysis title
    tamsulosin - medium dose vs. Placebo (Left Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-medium dose (MD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 65 (32 in tamsulosin-MD & 33 in placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
    Comparison groups
    tamsulosin - medium dose level v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9231
    Method
    Regression, Logistic
    Confidence interval
    Statistical analysis title
    tamsulosin - high dose vs. Placebo (Left Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-high dose (HD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 71 (38 in tamsulosin-HD & 33 in placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (80) does not reflect the actual number.
    Comparison groups
    tamsulosin - high dose level v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.636
    Method
    Regression, Logistic
    Confidence interval
    Statistical analysis title
    tamsulosin - low dose vs. Placebo (Right Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-low dose (LD) was compared to placebo. Fisher's exact test was used for this analysis. The actual number of patients responded is 66 (33 for tamsulosin-LD & 33 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
    Comparison groups
    tamsulosin - low dose level v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    tamsulosin-medium dose vs. Placebo (Right Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-medium dose (MD) was compared to placebo. Fisher's exact test was used for this analysis. The actual number of patients responded is 65 (32 for tamsulosin-MD & 33 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
    Comparison groups
    tamsulosin - medium dose level v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4925
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    tamsulosin - high dose vs. Placebo (Right Kidney)
    Statistical analysis description
    Patient responded to tamsulosin-high dose (HD) was compared to placebo. Fisher's exact test was used for this analysis. The actual number of patients responded is 71 (38 for tamsulosin-HD & 33 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (80) does not reflect the actual number.
    Comparison groups
    tamsulosin - high dose level v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4977
    Method
    Fisher exact
    Confidence interval

    Secondary: Change from baseline in urine volume at Week 14

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    End point title
    Change from baseline in urine volume at Week 14
    End point description
    Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14. The Full analysis set-catheter (FAS-CATH): Includes all patients in the treated set who received at least one dose of randomised treatment, were on a catheterisation regimen, and had at least one on-treatment catheterisation assessment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14
    End point values
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Number of subjects analysed
    24 [21]
    18 [22]
    16 [23]
    21 [24]
    Units: mL
        least squares mean (standard error)
    -2.3 ± 14
    -32.2 ± 15.5
    4.4 ± 16.3
    3.3 ± 14.2
    Notes
    [21] - Full analysis set-catheter (FAS-CATH), OT
    [22] - Full analysis set-catheter (FAS-CATH), OT
    [23] - Full analysis set-catheter (FAS-CATH), OT
    [24] - Full analysis set-catheter (FAS-CATH), OT
    Statistical analysis title
    tamsulosin - low dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - low dose level v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1373
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -69.66
         upper limit
    9.78
    Statistical analysis title
    tamsulosin - medium dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - medium dose level v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.744
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -34.26
         upper limit
    47.74
    Statistical analysis title
    tamsulosin - high dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - high dose level v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7703
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -32.63
         upper limit
    43.88

    Secondary: Change from baseline in number of times patient was wet at catheterisation

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    End point title
    Change from baseline in number of times patient was wet at catheterisation
    End point description
    Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14.
    End point values
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Number of subjects analysed
    24 [25]
    18 [26]
    16 [27]
    21 [28]
    Units: Participants
        least squares mean (standard error)
    0.3 ± 0.8
    -1.7 ± 0.9
    0 ± 0.9
    -0.4 ± 0.8
    Notes
    [25] - Full analysis set-catheter (FAS-CATH), OT
    [26] - Full analysis set-catheter (FAS-CATH), OT
    [27] - Full analysis set-catheter (FAS-CATH), OT
    [28] - Full analysis set-catheter (FAS-CATH), OT
    Statistical analysis title
    tamsulosin - low dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - low dose level v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0808
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.34
         upper limit
    0.26
    Statistical analysis title
    tamsulosin - medium dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - medium dose level v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8244
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.64
         upper limit
    2.11
    Statistical analysis title
    tamsulosin - high dose vs. Placebo
    Statistical analysis description
    ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
    Comparison groups
    tamsulosin - high dose level v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5045
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.96
         upper limit
    1.47

    Secondary: Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing,Electorocardiogram (ECG), Laboratory Values, Urinalysis and Cognitive Testing.

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    End point title
    Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing,Electorocardiogram (ECG), Laboratory Values, Urinalysis and Cognitive Testing.
    End point description
    Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, visual acuity, Cognitive Testing, Occurrence of treatment emergent adverse events (AEs ), Premature discontinuation of study drug due to AEs and Urinalysis. Relevant findings or worsening of baseline conditions were reported as adverse events (AEs). Treated Set (TS). All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
    End point type
    Secondary
    End point timeframe
    From first drug administration until 28 days after last study drug administration, upto 160 days
    End point values
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Number of subjects analysed
    18 [29]
    39 [30]
    24 [31]
    15 [32]
    Units: Participants
        Occurrence of treatment emergent AEs
    2
    4
    1
    2
        Premature discontinuation of study drug due to AEs
    1
    2
    0
    0
        Sinus tachycardia
    0
    0
    0
    1
    Notes
    [29] - Treated Set (TS)
    [30] - Treated Set (TS)
    [31] - Treated Set (TS)
    [32] - Treated Set (TS)
    No statistical analyses for this end point

    Secondary: Post void residual volume at Week 14

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    End point title
    Post void residual volume at Week 14
    End point description
    Median change from baseline to Week 14 in post void residual (mL) by study treatment. Treated Set (TS). Number of particiapants Analysed are the number of participants whose data were available for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14.
    End point values
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Number of subjects analysed
    31 [33]
    36 [34]
    34 [35]
    38 [36]
    Units: mL
        median (standard deviation)
    3 ± 80.28
    -19 ± 66.4
    -1.5 ± 92.33
    0 ± 58.67
    Notes
    [33] - Treated Set (TS)
    [34] - Treated Set (TS)
    [35] - Treated Set (TS)
    [36] - Treated Set (TS)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first drug administration until 28 days after last study drug administration, upto 160 days.
    Adverse event reporting additional description
    All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Reporting group title
    tamsulosin - low dose level
    Reporting group description
    Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Reporting group title
    tamsulosin - medium dose level
    Reporting group description
    Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. One subject randomised to tamsulosin - medium dose level was not treated. Although actual number of subjects started is 40, 39 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group title
    tamsulosin - high dose level
    Reporting group description
    Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.

    Serious adverse events
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 120 (0.83%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    1
    0
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 120 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Shunt malfunction
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 120 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 120 (0.83%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo tamsulosin - low dose level tamsulosin - medium dose level tamsulosin - high dose level
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 41 (31.71%)
    19 / 120 (15.83%)
    14 / 80 (17.50%)
    8 / 40 (20.00%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 120 (0.83%)
    5 / 80 (6.25%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    5
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 41 (14.63%)
    1 / 120 (0.83%)
    3 / 80 (3.75%)
    1 / 40 (2.50%)
         occurrences all number
    6
    1
    3
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 120 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    6 / 41 (14.63%)
    1 / 120 (0.83%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
         occurrences all number
    8
    1
    1
    0
    Vomiting
         subjects affected / exposed
    5 / 41 (12.20%)
    2 / 120 (1.67%)
    4 / 80 (5.00%)
    3 / 40 (7.50%)
         occurrences all number
    5
    2
    4
    4
    Infections and infestations
    Influenza
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 120 (2.50%)
    1 / 80 (1.25%)
    2 / 40 (5.00%)
         occurrences all number
    3
    3
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    1 / 41 (2.44%)
    5 / 120 (4.17%)
    4 / 80 (5.00%)
    4 / 40 (10.00%)
         occurrences all number
    1
    6
    5
    8
    Urinary tract infection
         subjects affected / exposed
    4 / 41 (9.76%)
    8 / 120 (6.67%)
    2 / 80 (2.50%)
    5 / 40 (12.50%)
         occurrences all number
    4
    10
    2
    5

    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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