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    Clinical Trial Results:
    Exploratory study of L.S.E.S.r. (PERMIXON® 160 mg hard capsule) versus Tamsulosine LP activity on inflammation biomarkers in the treatment of urinary symptoms related to BPH, A multinational, multicentric, randomised, double-blind, parallel-group prospective study

    Summary
    EudraCT number
    		 2011-005307-33
    Trial protocol
    		 FR   ES   IT   PT  
    Global end of trial date
    08 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2016
    First version publication date
    14 May 2016
    Other versions
    Summary report(s)
    		 P00048 GP 4 03

    Trial information

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    Trial identification
    Sponsor protocol code
    P00048 GP 4 03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01604811
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    PIERRE FABRE MEDICAMENT
    Sponsor organisation address
    Centre de Recherche et Développement, 3 avenue Hubert Curien, Toulouse, France, 31035
    Public contact
    Medical Manager Marie Thérèse PETRISSANS, PIERRE FABRE MEDICAMENT, marie.therese.petrissans@pierre-fabre.com
    Scientific contact
    Medical Manager Marie Thérèse PETRISSANS, PIERRE FABRE MEDICAMENT, marie.therese.petrissans@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
    11 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. at D30 and D90 on biomarkers of inflammation in patients suffering from BPH : - Urine inflammation markers on the first urine flow : gene (mRNA) expression profile of inflammation in BPH - Serum inflammation markers : CRP and Sedimentation Rate
    Protection of trial subjects
    The trial was conducted according to Good Clinical Practice (CPMP/ICH/135/95), the Declaration of Helsinki and its subsequent amendments thereto and local legal regulations. The study protocol and the informed consent form were submitted for approval to Ethics Committees before the study set up according to the national regulations. The patient underwent a health assessment at the start of the study and remained under regular medical control during the whole study. If necessary according to investigator’s opinion, the patient may be asked to attend an unscheduled visit. During the course of the study all patients received an active treatment approved in moderate micturition disorders related to benign prostatic hyperplasia, Permixon® 160 mg hard capsules or Tamsulosine LP. A run-in period of 28 to 42 days without treatment has been decided to have reliable baseline, which is not incompatible with the management of BPH disease including watchful waiting. All study procedures are usual in medical practice for BPH management. Antibiotics, NSAIDs and corticosteroids were allowed by local route during the course of the study. However, for ethical reasons, they may be prescribed by systemic route only in the interest of the patient's health if the investigator judges it necessary and if no alternative therapeutic drugs are possible to manage patient’s complaint (exp : paracetamol for pain).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jun 2012
    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
    Portugal: 11
    Country: Number of subjects enrolled
    Spain: 42
    Country: Number of subjects enrolled
    France: 163
    Country: Number of subjects enrolled
    Italy: 107
    Worldwide total number of subjects
    323
    EEA total number of subjects
    323
    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)
    150
    From 65 to 84 years
    172
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 42 sites were initiated in this multinationalstudy. There were 20 centres in France, 8 centres in Italy, 3 centres in Portugal and 11 centres in Spain. Among them, 36 sites selected at least 1 patient, 34 sites randomised at least 1 patient. 323 patients were screened, 206 were randomized, 203 were treated.

    Pre-assignment
    Screening details
    		 Male patient between 45-85 years old, Bothersome lower urinary tract symptoms existing for > 12 months I-PSS ≥ 10 at selection visit (V1)and ≥12 at randomization visit (V2) Serum tot PSA ≤4ng/ml or ≤10mg/ml and PSA(free)/PSA(tot) ≥25% or negative prostate biopsy within the past 6 months prior to selection Prostatic vol ≥30cm3 TRUS at V2

    Period 1
    Period 1 title
    Wash-out / run-in period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Run-in period
    Arm description
    		 3 of these patients were randomised in the Tamsulosine group but not treated.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Run-in period
    Started
    323
    Completed
    203
    Not completed
    120
         Not eligible
    81
         Other
    11
         Patient's decision
    28
    Period 2
    Period 2 title
    90-day treatment period FAS
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Permixon® 160 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Permixon® 160 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1 hard capsule (160 mg) twice daily

    Investigational medicinal product name
    Placebo matching Tamsulosine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule daily

    Arm title
    		 Tamsulosine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tamsulosine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule (0.4 mg) daily

    Investigational medicinal product name
    Placebo matching Permixon®160 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1 hard capsule twice daily

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 correspond to wash out/run in period during patients had to discontinue treatments such as NSAIDs, corticosteroids antibiotics..and perform biological analysis. Patients were randomised at V2 to either Permixon or Tamsulosine arm.
    Number of subjects in period 2 [2]
    		Permixon® 160 mg Tamsulosine
    Started
    102
    101
    Completed
    83
    86
    Not completed
    19
    15
         Knee arthroscopy
    -
    1
         Not eligible
    4
    -
         lack of efficacy and safety
    1
    -
         Patient's decision
    -
    1
         Adverse event, non-fatal
    7
    3
         Retroviral chronic infection
    1
    -
         Work troubles
    1
    -
         Inclusion wrongly
    -
    2
         IPSS score different
    1
    -
         Change of address
    1
    -
         Inclusion criteria not met
    -
    1
         Lack of efficacy
    2
    2
         Protocol deviation
    1
    2
         Patients not treated
    -
    3
    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: Worldwide enrolled number of patients corresponds to screened patients at V1 ie 323 patients, among them 303 were retained at selection visit and 206 were randomised (included in the study) at V2 (V2-90 days Baseline period)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Permixon® 160 mg
    Reporting group description
    		 -

    Reporting group title
    Tamsulosine
    Reporting group description
    		 -

    Reporting group values
    		 Permixon® 160 mg Tamsulosine Total
    Number of subjects
    		 102 101 203
    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 (full range (min-max))
    		 65.4 (46.7 to 83) 66.1 (49.4 to 88.6) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 102 101 203
    Total PSA
    Units: Subjects
        ≤4ng/ng/ml
    		 88 87 175
        ]4-10] ng/ml
    		 14 13 27
        >10 ng/ml
    		 0 1 1
    IPSS Score
    The International Prostate Symptom Score (I-PSS) was assessed on Selection visit, D1, D30 and D90. It is based on 7 questions. The overall score is the sum of all the 7 questions and therefore calculated out of a total of 35 points. For the analysis, the baseline value corresponded to the overall score of the last I-PSS filled before first study drug intake.
    Units: decimal
        arithmetic mean (full range (min-max))
    		 17.7 (11 to 28) 16.5 (12 to 30) -

    End points

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    End points reporting groups
    Reporting group title
    Run-in period
    Reporting group description
    		 3 of these patients were randomised in the Tamsulosine group but not treated.
    Reporting group title
    Permixon® 160 mg
    Reporting group description
    		 -

    Reporting group title
    Tamsulosine
    Reporting group description
    		 -

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CCL2

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CCL2 [1]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    35
    31
    Units: Patients
        Down-regulated
    13
    13
        No change
    4
    11
        Up-regulated
    18
    7
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CCL2

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CCL2 [2]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    35
    31
    Units: Patients
        Down-regulated
    17
    16
        No change
    9
    6
        Up-regulated
    11
    14
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CCR7

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CCR7 [3]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    2
    5
    Units: Patients
        Down-regulated
    2
    2
        No change
    0
    0
        Up-regulated
    0
    3
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CCR7

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CCR7 [4]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    2
    6
    Units: Patients
        Down-regulated
    1
    3
        No change
    1
    2
        Up-regulated
    0
    1
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CD40LG

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CD40LG [5]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    1
    0 [6]
    Units: Patients
        Down-regulated
    1
        No change
    0
        Up-regulated
    0
    Notes
    [6] - CD40LG was not expressed in LnCap and the Baseline could not be done for it.
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CD40LG

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CD40LG [7]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    0 [8]
    1
    Units: Patients
        Down-regulated
    1
        No change
    0
        Up-regulated
    0
    Notes
    [8] - CD40LG was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CTLA4

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CTLA4 [9]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    1
    0 [10]
    Units: Patients
        Down-regulated
    1
        No change
    0
        Up-regulated
    0
    Notes
    [10] - CTLA4 was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CTLA4

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CTLA4 [11]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: Patients
        Down-regulated
        No change
        Up-regulated
    Notes
    [12] - CTLA4 was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    [13] - CTLA4 was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CXCL10

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CXCL10 [14]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    25
    25
    Units: Patients
        Down-regulated
    7
    7
        No change
    4
    11
        Up-regulated
    14
    7
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CXCL10

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CXCL10 [15]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    29
    29
    Units: Patients
        Down-regulated
    10
    11
        No change
    8
    9
        Up-regulated
    11
    9
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CXCL6

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CXCL6 [16]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    32
    28
    Units: Patients
        Down-regulated
    9
    11
        No change
    8
    8
        Up-regulated
    15
    9
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CXCL6

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CXCL6 [17]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    30
    29
    Units: Patients
        Down-regulated
    12
    14
        No change
    8
    5
        Up-regulated
    10
    10
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: FGF2

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: FGF2 [18]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    15
    17
    Units: Patients
        Down-regulated
    7
    8
        No change
    4
    5
        Up-regulated
    4
    4
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: FGF2

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: FGF2 [19]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    16
    16
    Units: Patients
        Down-regulated
    9
    9
        No change
    4
    5
        Up-regulated
    3
    2
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: ICOS

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: ICOS [20]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    1
    0 [21]
    Units: Patients
        Down-regulated
    0
        No change
    0
        Up-regulated
    1
    Notes
    [21] - ICOS was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: ICOS

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: ICOS [22]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    0 [23]
    1
    Units: Patients
        Down-regulated
    0
        No change
    1
        Up-regulated
    0
    Notes
    [23] - ICOS was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: IL6

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: IL6 [24]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    10
    6
    Units: Patients
        Down-regulated
    2
    2
        No change
    2
    2
        Up-regulated
    6
    2
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: IL6

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: IL6 [25]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    8
    12
    Units: Patients
        Down-regulated
    5
    9
        No change
    0
    2
        Up-regulated
    3
    1
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: IL15

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: IL15 [26]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    22
    21
    Units: Patients
        Down-regulated
    3
    6
        No change
    11
    9
        Up-regulated
    8
    6
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: IL15

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: IL15 [27]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    19
    21
    Units: Patients
        Down-regulated
    5
    11
        No change
    8
    6
        Up-regulated
    6
    4
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: IL17A

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: IL17A [28]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    0 [29]
    1
    Units: Patients
        Down-regulated
    1
        No change
    0
        Up-regulated
    0
    Notes
    [29] - IL17A was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: IL17A

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: IL17A [30]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    0 [31]
    1
    Units: Patients
        Down-regulated
    1
        No change
    0
        Up-regulated
    0
    Notes
    [31] - IL17A was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: ALOX15

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: ALOX15 [32]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    20
    15
    Units: Patients
        Down-regulated
    6
    8
        No change
    6
    3
        Up-regulated
    8
    4
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: ALOX15

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: ALOX15 [33]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    19
    20
    Units: Patients
        Down-regulated
    8
    12
        No change
    5
    5
        Up-regulated
    6
    3
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: LTC4S

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: LTC4S [34]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    26
    23
    Units: Patients
        Down-regulated
    5
    6
        No change
    10
    12
        Up-regulated
    11
    5
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: LTC4S

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: LTC4S [35]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    32
    27
    Units: Patients
        Down-regulated
    11
    11
        No change
    10
    10
        Up-regulated
    11
    6
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: SELP

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: SELP [36]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    0 [37]
    0 [38]
    Units: Patients
        Down-regulated
        No change
        Up-regulated
    Notes
    [37] - SELP was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    [38] - SELP was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: SELP

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: SELP [39]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    0 [40]
    0 [41]
    Units: Patients
        Down-regulated
        No change
        Up-regulated
    Notes
    [40] - SELP was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    [41] - SELP was not expressed in LnCap and the Baseline efficacy criteria could not be done for it.
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: PTPRC

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: PTPRC [42]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    32
    31
    Units: Patients
        Down-regulated
    10
    12
        No change
    5
    10
        Up-regulated
    17
    9
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D930 (V4) compared to baseline: PTPRC

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D930 (V4) compared to baseline: PTPRC [43]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    40
    36
    Units: Patients
        Down-regulated
    20
    13
        No change
    6
    8
        Up-regulated
    14
    15
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: ALOX15B

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: ALOX15B [44]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    72
    61
    Units: Patients
        Down-regulated
    16
    8
        No change
    49
    41
        Up-regulated
    7
    12
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: ALOX15B

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: ALOX15B [45]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    75
    62
    Units: Patients
        Down-regulated
    10
    11
        No change
    53
    36
        Up-regulated
    12
    15
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CAT

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CAT [46]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    82
    81
    Units: Patients
        Down-regulated
    17
    13
        No change
    49
    49
        Up-regulated
    16
    19
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CAT

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CAT [47]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    80
    80
    Units: Patients
        Down-regulated
    12
    11
        No change
    53
    46
        Up-regulated
    15
    23
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CCL5

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: CCL5 [48]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    13
    20
    Units: Patients
        Down-regulated
    4
    11
        No change
    3
    5
        Up-regulated
    6
    4
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CCL5

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: CCL5 [49]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    17
    21
    Units: Patients
        Down-regulated
    10
    11
        No change
    4
    4
        Up-regulated
    3
    6
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: HIF1A

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: HIF1A [50]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    84
    80
    Units: Patients
        Down-regulated
    19
    17
        No change
    44
    42
        Up-regulated
    21
    21
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: HIF1A

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: HIF1A [51]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As in an exploratory trial with no conclusive statistical interpretation, the analysis were only descriptive analysis per arm of treatment
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    82
    79
    Units: Patients
        Down-regulated
    21
    12
        No change
    49
    42
        Up-regulated
    12
    25
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: MIF

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: MIF [52]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As in an exploratory trial with no conclusive statistical interpretation, the analysis were only descriptive analysis per arm of treatment
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    86
    83
    Units: Patients
        Down-regulated
    10
    14
        No change
    56
    56
        Up-regulated
    20
    13
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: MIF

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: MIF [53]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As in an exploratory trial with no conclusive statistical interpretation, the analysis were only descriptive analysis per arm of treatment
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    82
    83
    Units: Patients
        Down-regulated
    9
    8
        No change
    56
    56
        Up-regulated
    17
    19
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: NFKB1

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: NFKB1 [54]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    72
    69
    Units: Patients
        Down-regulated
    17
    17
        No change
    37
    43
        Up-regulated
    18
    9
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: NFKB1

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: NFKB1 [55]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    75
    68
    Units: Patients
        Down-regulated
    22
    20
        No change
    41
    31
        Up-regulated
    12
    17
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: PTGES2

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: PTGES2 [56]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    75
    70
    Units: Patients
        Down-regulated
    13
    12
        No change
    46
    49
        Up-regulated
    16
    9
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: PTGES2

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: PTGES2 [57]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    77
    69
    Units: Patients
        Down-regulated
    18
    14
        No change
    39
    42
        Up-regulated
    20
    13
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: PTGES3

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: PTGES3 [58]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    81
    75
    Units: Patients
        Down-regulated
    13
    13
        No change
    50
    51
        Up-regulated
    18
    11
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: PTGES3

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: PTGES3 [59]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    80
    79
    Units: Patients
        Down-regulated
    21
    12
        No change
    46
    46
        Up-regulated
    13
    21
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: PTGS2

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: PTGS2 [60]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [60] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    49
    48
    Units: Patients
        Down-regulated
    20
    15
        No change
    17
    23
        Up-regulated
    12
    10
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: PTGS2

    		 Close Top of page
    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: PTGS2 [61]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    54
    51
    Units: Patients
        Down-regulated
    19
    19
        No change
    21
    23
        Up-regulated
    14
    9
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: STAT3

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: STAT3 [62]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [62] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    82
    74
    Units: Patients
        Down-regulated
    17
    11
        No change
    48
    46
        Up-regulated
    17
    17
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: STAT3

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: STAT3 [63]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    81
    72
    Units: Patients
        Down-regulated
    15
    9
        No change
    51
    48
        Up-regulated
    15
    15
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: IL1B

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: IL1B [64]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [64] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    58
    54
    Units: Patients
        Down-regulated
    24
    26
        No change
    15
    18
        Up-regulated
    19
    10
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: IL1B

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: IL1B [65]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [65] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    60
    57
    Units: Patients
        Down-regulated
    24
    32
        No change
    16
    10
        Up-regulated
    20
    15
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: IL8

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: IL8 [66]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    73
    63
    Units: Patients
        Down-regulated
    33
    34
        No change
    12
    18
        Up-regulated
    28
    11
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: IL8

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: IL8 [67]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [67] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    73
    68
    Units: Patients
        Down-regulated
    35
    33
        No change
    18
    13
        Up-regulated
    20
    22
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: PLA2G2A

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D30 (V3) compared to baseline: PLA2G2A [68]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [68] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    72
    70
    Units: Patients
        Down-regulated
    11
    14
        No change
    46
    45
        Up-regulated
    15
    11
    No statistical analyses for this end point

    Primary: Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: PLA2G2A

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    End point title
    		 Clinical response based on fold change in urine inflammation markers at D90 (V4) compared to baseline: PLA2G2A [69]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    75
    74
    Units: Patients
        Down-regulated
    13
    16
        No change
    48
    42
        Up-regulated
    14
    16
    No statistical analyses for this end point

    Primary: CRP: change from baseline to D30 (V3)

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    End point title
    		 CRP: change from baseline to D30 (V3) [70]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [70] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As in an exploratory trial with no conclusive statistical interpretation, the analysis were only descriptive analysis per arm of treatment
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    91
    86
    Units: Patients
        Normal to normal
    73
    71
        Normal to abnormal
    5
    5
        Abnormal to normal
    6
    7
        Abnormal to abnormal
    7
    3
    No statistical analyses for this end point

    Primary: CRP: change from baseline to D90 (V4)

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    End point title
    		 CRP: change from baseline to D90 (V4) [71]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [71] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As in an exploratory trial with no conclusive statistical interpretation, the analysis were only descriptive analysis per arm of treatment
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    82
    81
    Units: Patients
        Normal to normal
    67
    67
        Normal to abnormal
    4
    4
        Abnormal to normal
    7
    5
        Abnormal to abnormal
    4
    5
    No statistical analyses for this end point

    Primary: Sedimentation rate at 1 hour: change from baseline to D30

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    End point title
    		 Sedimentation rate at 1 hour: change from baseline to D30 [72]
    End point description
    End point type
    Primary
    End point timeframe
    D30 (V3)
    Notes
    [72] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    82
    78
    Units: Patients
        Normal to normal
    63
    69
        Normal to abnormal
    5
    3
        Abnormal to normal
    4
    1
        Abnormal to abnormal
    10
    5
    No statistical analyses for this end point

    Primary: Sedimentation rate at 1 hour: from baseline to D90

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    End point title
    		 Sedimentation rate at 1 hour: from baseline to D90 [73]
    End point description
    End point type
    Primary
    End point timeframe
    D90 (V4)
    Notes
    [73] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis
    End point values
    		 Permixon® 160 mg Tamsulosine
    Number of subjects analysed
    76
    73
    Units: Patients
        Normal to normal
    59
    62
        Normal to abnormal
    4
    5
        Abnormal to normal
    5
    1
        Abnormal to abnormal
    8
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the whole duration of the trial (from the signature of the consent for one subject)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Permixon® 160 mg
    Reporting group description
    		 -

    Reporting group title
    Tamsulosine
    Reporting group description
    		 -

    Reporting group title
    Wash-out / Run-in period
    Reporting group description
    		 -

    Serious adverse events
    		 Permixon® 160 mg Tamsulosine Wash-out / Run-in period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 102 (1.96%)
    2 / 101 (1.98%)
    4 / 323 (1.24%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoformation of gallbladder
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (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
    B cell non-Hodgkin lymphoma
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (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
    malignant ampuloma
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 323 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Bilateral gynecomastia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 323 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 323 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Aggravation of lumbar spinal stenosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (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
    Hernia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 323 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Permixon® 160 mg Tamsulosine Wash-out / Run-in period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 102 (25.49%)
    25 / 101 (24.75%)
    14 / 323 (4.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 101 (0.00%)
    4 / 323 (1.24%)
         occurrences all number
    2
    0
    4
    Orthostatic hypotension
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    3
    0
    0
    Surgical and medical procedures
    Knee arthroplasty
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 102 (0.98%)
    2 / 101 (1.98%)
    1 / 323 (0.31%)
         occurrences all number
    1
    2
    1
    Asthenia
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 101 (1.98%)
    0 / 323 (0.00%)
         occurrences all number
    0
    2
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Retrograde ejaculation
         subjects affected / exposed
    0 / 102 (0.00%)
    4 / 101 (3.96%)
    0 / 323 (0.00%)
         occurrences all number
    0
    4
    0
    Ejaculation failure
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 101 (1.98%)
    0 / 323 (0.00%)
         occurrences all number
    0
    2
    0
    Genital discomfort
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Testicular pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Libido decreased
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Nightmare
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Anorgasmia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    C-reactive protein
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Weight increased
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    3
    0
    0
    Balance disorder
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Dysaesthesia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Migraine
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    1 / 323 (0.31%)
         occurrences all number
    1
    1
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    1
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 101 (2.97%)
    0 / 323 (0.00%)
         occurrences all number
    0
    3
    0
    Anal fissure
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 323 (0.31%)
         occurrences all number
    0
    1
    1
    Flatulence
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 102 (0.98%)
    2 / 101 (1.98%)
    0 / 323 (0.00%)
         occurrences all number
    1
    2
    0
    Dermatitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus allergic
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    2
    1
    0
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    1
    1
    0
    Joint effusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Pubic pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 101 (2.97%)
    1 / 323 (0.31%)
         occurrences all number
    0
    3
    1
    Muscular weakness
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 323 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 101 (1.98%)
    2 / 323 (0.62%)
         occurrences all number
    0
    2
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 101 (1.98%)
    1 / 323 (0.31%)
         occurrences all number
    0
    2
    1
    Ear infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 323 (0.31%)
         occurrences all number
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 323 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Nov 2012
    Modification of prior or concomitant treatments Clarification of wash-out period in non-inclusion criteria related to treatments and prohibited treatments sections.
    29 Jan 2013
    Addition of adverse effects linked to Tamsulosine and Permixon and of a warning regarding concomitant administration of Tamsulosine with potent CYP3A4 inhibitors in CYP2D6 poor metabolizers patients
    19 Jun 2013
    Exploration of the arachidonic acid pathway and extension of the analysis of markers with: ALOX15, ALOX15B, ALOX5, CAT, CCL5, HIF1A, LTC4S, MIF, NFKB1, PTGES2, PTGES3, PTGS2, PTPRC, SELP, STAT3

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26306400
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