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    Clinical Trial Results:
    PERMIXON® 160 mg hard capsule versus placebo in the treatment of symptomatic lower urinary tract symptoms due to benign prostatic hyperplasia.

    Summary
    EudraCT number
    2014-000222-38
    Trial protocol
    IT   ES   CZ   DE   FR  
    Global end of trial date
    27 Jun 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Jul 2017
    First version publication date
    12 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P00048GP404
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    PIERRE FABRE MEDICAMENT
    Sponsor organisation address
    45 Place Abel Gance, Boulogne, France, 92100
    Public contact
    Montagne Agnes, Institut de Recherche Pierre Fabre, 33 534506350, agnes.montagne@pierre-fabre.com
    Scientific contact
    Montagne Agnes, Institut de Recherche Pierre Fabre, 33 534506350, agnes.montagne@pierre-fabre.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare at 6 months (D180) the efficacy of PERMIXON® 160 mg b.i.d to a placebo in patients with lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) through the assessment of I-PSS. This study was placebo-controlled and reference active treatment-controlled. The placebo group received the same medical care as the test active treatment group (Permixon) and the positive control group (Tamsulosin) according to that which would have been provided if they had not participated in the study.
    Protection of trial subjects
    The study was performed in accordance with the current version of the Declaration of Helsinki (1964 and its subsequent amendments). The study was conducted in agreement with the International Conference on Harmonisation (ICH) guidelines on Good Clinical Practice (GCP), and with related national regulation in biomedical research. The first study protocol in use (V1, 7 February 2014), and the patient information sheets were reviewed and approved by the appropriate IECs. There were no substantial subsequent amendments. This study was placebo-controlled and active reference-controlled (see rationale in "Evidence for comparator caption". The placebo group received the same medical care as the test treatment group (Permixon) and the positive control group (Tamsulosin), according to that which would have been provided if they had not participated in the trial. Patients were free to withdraw from the study at any time for any reason. The investigator could decide to withdraw a patient from the study due to tolerability/safety/efficacy issues if it was felt to be in the patient’s best interests.
    Background therapy
    In order to differentiate between treatment effects both on efficacy and safety during the comparative treatment phase, included patients were naïve to any prior treatment for LUTS/BPH. There was no systematic concomitant administration of any other product than investigational products.
    Evidence for comparator
    This study was placebo-controlled to demonstrate the efficacy of Permixon in treating LUTS/BPH. LUTS/BPH is not often a life-threatening condition. The primary treatment goal for BPH is to alleviate bothersome LUTS that result from prostatic enlargement and improve patients’ quality of life. alpha1-blockers, 5alpha reductase inhibitors (5 ARIs), antimuscarinics, and phosphodiesterase type 5 inhibitors, either alone or in combination, are the standards of care for uncomplicated bothersome LUTS/BPH unresponsive to behavioural management, but present safety/tolerability issues such as orthostatic hypotension and retrograde ejaculation for alpha1-blockers and sexual dysfunction for 5-ARIs. In this context, a placebo is the indicated comparator. Tamsulosine Arrow LP 0.4 mg is the most widely used medication for the treatment of symptoms related to BPH and was found to be well tolerated and clinically effective on symptoms and urinary flow in several placebo-controlled trials at the dose of 0.4 mg/day; thus it was used as a positive control in order to validate the sensitivity of the study for all efficacy analyses.
    Actual start date of recruitment
    07 May 2014
    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: 81
    Country: Number of subjects enrolled
    Czech Republic: 215
    Country: Number of subjects enrolled
    France: 190
    Country: Number of subjects enrolled
    Germany: 106
    Country: Number of subjects enrolled
    Italy: 192
    Worldwide total number of subjects
    784
    EEA total number of subjects
    784
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    427
    From 65 to 84 years
    357
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    68 centres recruited patients: 18 in Italy, 18 in France, 12 in Germany, 12 in Spain, and 8 in the Czech Republic.. 811 patients were screened, 784 enrolled, 608 randomised. An additional 22 screened patients (12 enrolled, 2 randomised) from 1 centre in France (#0514) were excluded from all analyses due to serious breach of GCP and protocol.

    Pre-assignment
    Screening details
    Male patients aged 45-85 years with symptomatic LUTS/BPH (I-PSS score > 12 and QoL I-PSS ≥ 3); LUTS/BPH-treatment naïve; with no historical/concomitant urinary tract disease with a potential impact on the treatment response. An I-PSS score change <3 during a 1-month placebo run-in period was required to enter the treatment period.

    Period 1
    Period 1 title
    Placebo Run-in Period
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject
    Blinding implementation details
    As for the treatment period, blinding was ensured by a double dummy process i.e. identical: - colour, size and aspect of placebo1 and Permixon capsules and of placebo2 and Tamsulosin capsules - packaging, labelling and administration of study products.

    Arms
    Arm title
    Placebo run-in
    Arm description
    All patients enrolled
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo 1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    BID administration: two capsules per day = one capsule in the morning and one capsule in the evening

    Investigational medicinal product name
    Placebo 2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    QD administration: one capsule per day, in the morning

    Number of subjects in period 1
    Placebo run-in
    Started
    784
    Completed
    608
    Not completed
    176
         Other commitment (holiday, travel)
    1
         Eligibility criteria not met
    138
         Consent withdrawn by subject
    37
    Period 2
    Period 2 title
    Treatment Period
    Is this the baseline period?
    Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Double-blinding was ensured by a double dummy process i.e. identical: - colour, size and aspect of placebo1 and Permixon capsules and of placebo2 and Tamsulosin capsules - packaging, labelling and administration of study products.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Patients randomised at Visit 2 to placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo 1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    BID administration: two capsules per day = one capsule in the morning and one capsule in the evening

    Investigational medicinal product name
    Placebo 2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    qd administration: one capsule per day in the morning

    Arm title
    Permixon
    Arm description
    Patients randomised at Visit 2 to Permixon
    Arm type
    Experimental

    Investigational medicinal product name
    Permixon
    Investigational medicinal product code
    P0048
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    BID administration: two capsules per day = one capsule in the morning; one capsule in the evening

    Arm title
    Tamsulosin
    Arm description
    Patients randomised at visit 2 to tamsulosin
    Arm type
    Positive control

    Investigational medicinal product name
    Tamsulosine Arrow LP 0.4 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    qd administration: 1 capsule per day in the morning

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Patients could enter the comparative treatment period only if they had completed Period 1 (run-in period) with an I-PSS change <3 during this period. Their Baseline efficacy characteristics were measured at the beginning of Period 2.
    Number of subjects in period 2 [2]
    Placebo Permixon Tamsulosin
    Started
    202
    201
    205
    Completed
    177
    170
    173
    Not completed
    25
    31
    32
         Protocol deviation
    -
    2
    4
         Other commitment (holiday, travel)
    2
    1
    1
         Eligibility criteria not met
    2
    5
    4
         Lack of efficacy
    10
    8
    5
         Adverse event, non-fatal
    5
    6
    14
         Consent withdrawn by subject
    6
    9
    4
    Notes
    [2] - 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: Enrolled patients (n=784) were the patients entering the placebo run-in period Randomised patients (n=608) were the patients having completed the placebo run-in period with an I-PSS change <3 during this period. These patients could enter the comparative treatment period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Patients randomised at Visit 2 to placebo

    Reporting group title
    Permixon
    Reporting group description
    Patients randomised at Visit 2 to Permixon

    Reporting group title
    Tamsulosin
    Reporting group description
    Patients randomised at visit 2 to tamsulosin

    Reporting group values
    Placebo Permixon Tamsulosin Total
    Number of subjects
    202 201 205 608
    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)
    62.6 ± 8.6 63.4 ± 8.5 62.8 ± 8.5 -
    Gender categorical
    Units: Subjects
        Female
    0 0 0 0
        Male
    202 201 205 608
    Time to BPH diagnosis
    Units: years
        arithmetic mean (standard deviation)
    1.66 ± 3.28 1.94 ± 3.58 1.86 ± 3.52 -
    I-PSS
    Units: Points
        arithmetic mean (standard deviation)
    17.5 ± 3.6 17.3 ± 3.6 17.6 ± 4 -
    QoL-I-PSS
    Units: Points
        arithmetic mean (standard deviation)
    3.8 ± 1 3.8 ± 0.8 3.9 ± 0.9 -
    MSF-4
    Units: Points
        arithmetic mean (standard deviation)
    8.2 ± 4.6 8.1 ± 4.7 7.6 ± 4.7 -
    Subject analysis sets

    Subject analysis set title
    Randomised set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All randomised patients, whether treated or not, were analysed for efficacy

    Subject analysis sets values
    Randomised set
    Number of subjects
    608
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.9 ± 8.5
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    608
    Time to BPH diagnosis
    Units: years
        arithmetic mean (standard deviation)
    1.82 ± 3.46
    I-PSS
    Units: Points
        arithmetic mean (standard deviation)
    17.5 ± 3.7
    QoL-I-PSS
    Units: Points
        arithmetic mean (standard deviation)
    3.9 ± 0.9
    MSF-4
    Units: Points
        arithmetic mean (standard deviation)
    8 ± 4.6

    End points

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    End points reporting groups
    Reporting group title
    Placebo run-in
    Reporting group description
    All patients enrolled
    Reporting group title
    Placebo
    Reporting group description
    Patients randomised at Visit 2 to placebo

    Reporting group title
    Permixon
    Reporting group description
    Patients randomised at Visit 2 to Permixon

    Reporting group title
    Tamsulosin
    Reporting group description
    Patients randomised at visit 2 to tamsulosin

    Subject analysis set title
    Randomised set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All randomised patients, whether treated or not, were analysed for efficacy

    Primary: I-PSS change from baseline to D180 (permixon vs placebo)

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    End point title
    I-PSS change from baseline to D180 (permixon vs placebo) [1]
    End point description
    I-PSS score (range: 0-35) measures LUTS. A decrease indicates an improvement of symptoms
    End point type
    Primary
    End point timeframe
    From Baseline to Day 180
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Efficacy endpoints were analysed between Placebo and Permixon arms and between Placebo and Tamsulosin arms, separately; so they were also defined separately.
    End point values
    Placebo Permixon
    Number of subjects analysed
    202
    201
    Units: Points
        least squares mean (standard error)
    -4.41 ± 0.4
    -4.51 ± 0.4
    Statistical analysis title
    ANCOVA
    Statistical analysis description
    Covariance analysis after LOCF imputation of missing data. The model incorporated I-PSS score change during the run-in period and baseline I-PSS score as covariates and country as stratum factor.
    Comparison groups
    Placebo v Permixon
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.833
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.14
         upper limit
    0.92
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.52

    Secondary: I-PSS change from baseline to D180 (tamsulosin vs placebo)

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    End point title
    I-PSS change from baseline to D180 (tamsulosin vs placebo) [2]
    End point description
    I-PSS score (range: 0-35) measures LUTS. A decrease indicates an improvement of symptoms
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 180
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Efficacy endpoints were analysed between Placebo and Permixon arms and between Placebo and Tamsulosin arms, separately; so they were also defined separately.
    End point values
    Placebo Tamsulosin
    Number of subjects analysed
    202
    205
    Units: Points
        least squares mean (standard error)
    -4.48 ± 0.39
    -5.24 ± 0.38
    Statistical analysis title
    ANCOVA
    Statistical analysis description
    Covariance analysis after LOCF imputation of missing data. The model incorporated I-PSS score change during the run-in period and baseline I-PSS score as covariates and country as stratum factor.
    Comparison groups
    Placebo v Tamsulosin
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.133
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.75
         upper limit
    0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5

    Secondary: MSF-4 change from baseline to D180 (permixon vs placebo)

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    End point title
    MSF-4 change from baseline to D180 (permixon vs placebo) [3]
    End point description
    MSF4 total score (range: 0 to 5) measures male sexual function. An increase indicates a deterioration of the sexual function
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 180
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Efficacy endpoints were analysed between Placebo and Permixon arms and between Placebo and Tamsulosin arms, separately; so they were also defined separately.
    End point values
    Placebo Permixon
    Number of subjects analysed
    202
    201
    Units: Points
        least squares mean (standard error)
    -0.28 ± 0.2
    0.06 ± 0.2
    Statistical analysis title
    ANCOVA
    Statistical analysis description
    Analysis of covariance using LOCF imputation of missing data. The model incorporated baseline MSF-4 score as covariate and country as stratum factor.
    Comparison groups
    Permixon v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.187
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.34
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.16
         upper limit
    0.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26

    Secondary: MSF-4 change from baseline to D180 (tamsulosin vs placebo)

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    End point title
    MSF-4 change from baseline to D180 (tamsulosin vs placebo) [4]
    End point description
    MSF4 total score (range: 0 to 5) measures male sexual function. An increase indicates a deterioration of the sexual function
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 180
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Efficacy endpoints were analysed between Placebo and Permixon arms and between Placebo and Tamsulosin arms, separately; so they were also defined separately.
    End point values
    Placebo Tamsulosin
    Number of subjects analysed
    202
    205
    Units: Points
        least squares mean (standard error)
    -0.26 ± 0.2
    0.59 ± 0.2
    Statistical analysis title
    ANCOVA
    Statistical analysis description
    Analysis of covariance using LOCF imputation of missing data. The model incorporated the baseline MSF-4 score as covariate and country as stratum factor.
    Comparison groups
    Placebo v Tamsulosin
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.84
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.32
         upper limit
    1.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.27

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Over the treatment period (180 days +/- 10 days) for al AEs and + 30 days post-end of study visit
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Patients randomised at Visit 2 to placebo and having taken at least one dose of study treatment

    Reporting group title
    Permixon
    Reporting group description
    Patients randomised at Visit 2 to Permixon and having taken at least one dose of treatment

    Reporting group title
    Tamsulosin
    Reporting group description
    Patients randomised at Visit 2 to Tamsulosin and having taken at least one dose of study treatment

    Serious adverse events
    Placebo Permixon Tamsulosin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 201 (2.99%)
    4 / 199 (2.01%)
    6 / 205 (2.93%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Varicose vein
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 199 (0.00%)
    0 / 205 (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
    Injury, poisoning and procedural complications
    Tendon rupture
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 199 (0.00%)
    0 / 205 (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
    Surgical and medical procedures
    Prepuce dorsal slit
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 199 (0.00%)
    0 / 205 (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
    Varicose vein operation
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 199 (0.00%)
    0 / 205 (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
    Knee arthroplasty
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 199 (0.50%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 199 (0.00%)
    0 / 205 (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
    Coronary artery disease
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 199 (0.00%)
    2 / 205 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 199 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 199 (0.00%)
    0 / 205 (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
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 199 (0.00%)
    0 / 205 (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
    Prostate cancer
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 199 (0.50%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 199 (0.50%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 199 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Diverticulitis
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 199 (0.50%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device use error
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 199 (0.00%)
    1 / 205 (0.49%)
         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
    Proteinuria
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 199 (0.00%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1.5%
    Non-serious adverse events
    Placebo Permixon Tamsulosin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 201 (28.86%)
    43 / 199 (21.61%)
    52 / 205 (25.37%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    9 / 201 (4.48%)
    7 / 199 (3.52%)
    3 / 205 (1.46%)
         occurrences all number
    10
    7
    3
    Hypertension
         subjects affected / exposed
    1 / 201 (0.50%)
    2 / 199 (1.01%)
    3 / 205 (1.46%)
         occurrences all number
    1
    2
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 199 (0.00%)
    5 / 205 (2.44%)
         occurrences all number
    0
    0
    5
    Headache
         subjects affected / exposed
    2 / 201 (1.00%)
    3 / 199 (1.51%)
    3 / 205 (1.46%)
         occurrences all number
    2
    3
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 201 (1.49%)
    1 / 199 (0.50%)
    0 / 205 (0.00%)
         occurrences all number
    3
    1
    0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    0 / 201 (0.00%)
    3 / 199 (1.51%)
    0 / 205 (0.00%)
         occurrences all number
    0
    3
    0
    Reproductive system and breast disorders
    Retrograde ejaculation
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 199 (0.50%)
    4 / 205 (1.95%)
         occurrences all number
    0
    1
    4
    Erectile dysfunction
         subjects affected / exposed
    3 / 201 (1.49%)
    0 / 199 (0.00%)
    3 / 205 (1.46%)
         occurrences all number
    4
    0
    3
    Ejaculation failure
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 199 (0.00%)
    3 / 205 (1.46%)
         occurrences all number
    1
    0
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 201 (1.49%)
    2 / 199 (1.01%)
    2 / 205 (0.98%)
         occurrences all number
    3
    2
    2
    Infections and infestations
    influenza
         subjects affected / exposed
    3 / 201 (1.49%)
    1 / 199 (0.50%)
    2 / 205 (0.98%)
         occurrences all number
    3
    1
    2

    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.
    As for Permixon, the efficacy of the positive control Tamsulosin vs placebo was not demonstrated which makes the study non conclusive. A high placebo effect was not minimised by the exclusion of placebo responders at the end of the run-in period.
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