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    Clinical Trial Results:
    Aprepitant in histamine-refractory chronic pruritus: a multicenter, randomized, double-blind, placebo-controlled, cross-over, phase II trial

    Summary
    EudraCT number
    		 2013-001601-85
    Trial protocol
    		 DE  
    Global end of trial date
    04 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jan 2017
    First version publication date
    08 Jan 2017
    Other versions
    Summary report(s)
    		 APREPRU

    Trial information

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    Trial identification
    Sponsor protocol code
    UKM10_0037
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1140-6701
    Sponsors
    Sponsor organisation name
    University Hospital Münster
    Sponsor organisation address
    Von-Esmach-Str. 58, Münster, Germany, 48149
    Public contact
    Competence Center Chronic Pruritus, University Hospital Münster, Department of Dermatology, sonja.staender@ukmuenster.de
    Scientific contact
    Competence Center Chronic Pruritus, University Hospital Münster, Department of Dermatology, sonja.staender@ukmuenster.de
    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
    08 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of aprepitant relative to placebo in reducing chronic pruritus according to the Patient Global Assessment (PGA) as measured by the Visual Ana-logue Scale (VAS, average itch, visit-obtained)
    Protection of trial subjects
    None
    Background therapy
    		 Patients were allowed to use emollients including urea which is known to have antipruritic properties in addition to the trial medication. Any other medication taken for any medical condition had to be documented in the patient`s file. If patients needed systemic rescue medication, cetirizine had to be used and documented in the patient´s file. This was not a drop-out criterion but was analyzed as secondary endpoint.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    46
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 58 patients were recruited at 5 centers within Germay (Muenster, Gera, Mainz, Berlin, Hannover).

    Pre-assignment
    Screening details
    		 67 patients were screened, of which 58 were enrolled.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aprepitant in first period, placebo in second period
    Arm description
    		 The patients in this arm received aprepitant in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received placebo in the second treatment-period (daily, 4 weeks).
    Arm type
    		 Cross-over arm A

    Investigational medicinal product name
    Aprepitant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    80mg , once daily

    Arm title
    		 Placebo in first period, aprepitant in second period
    Arm description
    		 The patients in this arm received placebo in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received aprepitant in the second treatment-period (daily, 4 weeks).
    Arm type
    		 Cross-over arm B

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    One capsula daily

    Number of subjects in period 1
    		Aprepitant in first period, placebo in second period Placebo in first period, aprepitant in second period
    Started
    30
    28
    Completed
    30
    28
    Period 2
    Period 2 title
    First treatment-period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aprepritant in first period, placebo in second period
    Arm description
    		 The patients in this arm received aprepitant in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received placebo in the second treatment-period (daily, 4 weeks).
    Arm type
    		 Cross-over arm A

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo in first period, aprepritant in second period
    Arm description
    		 The patients in this arm received placebo in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received aprepritant in the second treatment-period (daily, 4 weeks).
    Arm type
    		 Cross-over arm B

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Aprepritant in first period, placebo in second period Placebo in first period, aprepritant in second period
    Started
    30
    28
    Completed
    28
    25
    Not completed
    2
    3
         Consent withdrawn by subject
    2
    3
    Period 3
    Period 3 title
    Second treatment-period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aprepritant in first period, placebo in second period
    Arm description
    		 The patients in this arm received aprepitant in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received placebo in the second treatment-period (daily, 4 weeks).
    Arm type
    		 Cross-over arm A

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo in first period, aprepritant in second period
    Arm description
    		 The patients in this arm received placebo in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received aprepritant in the second treatment-period (daily, 4 weeks).
    Arm type
    		 Cross-over arm B

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3 [1]
    		Aprepritant in first period, placebo in second period Placebo in first period, aprepritant in second period
    Started
    28
    22
    Completed
    28
    22
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: After the end of treatment-period 1, a two-week wash-out period started. Some patients dropped out during the wash-out period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aprepitant in first period, placebo in second period
    Reporting group description
    		 The patients in this arm received aprepitant in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received placebo in the second treatment-period (daily, 4 weeks).

    Reporting group title
    Placebo in first period, aprepitant in second period
    Reporting group description
    		 The patients in this arm received placebo in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received aprepitant in the second treatment-period (daily, 4 weeks).

    Reporting group values
    		 Aprepitant in first period, placebo in second period Placebo in first period, aprepitant in second period Total
    Number of subjects
    		 30 28 58
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 22 24 46
        From 65-84 years
    		 8 4 12
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 58.5 (52 to 65) 58 (46 to 61.5) -
    Gender categorical
    Units: Subjects
        Female
    		 12 15 27
        Male
    		 18 13 31

    End points

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    End points reporting groups
    Reporting group title
    Aprepitant in first period, placebo in second period
    Reporting group description
    		 The patients in this arm received aprepitant in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received placebo in the second treatment-period (daily, 4 weeks).

    Reporting group title
    Placebo in first period, aprepitant in second period
    Reporting group description
    		 The patients in this arm received placebo in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received aprepitant in the second treatment-period (daily, 4 weeks).
    Reporting group title
    Aprepritant in first period, placebo in second period
    Reporting group description
    		 The patients in this arm received aprepitant in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received placebo in the second treatment-period (daily, 4 weeks).

    Reporting group title
    Placebo in first period, aprepritant in second period
    Reporting group description
    		 The patients in this arm received placebo in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received aprepritant in the second treatment-period (daily, 4 weeks).
    Reporting group title
    Aprepritant in first period, placebo in second period
    Reporting group description
    		 The patients in this arm received aprepitant in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received placebo in the second treatment-period (daily, 4 weeks).

    Reporting group title
    Placebo in first period, aprepritant in second period
    Reporting group description
    		 The patients in this arm received placebo in the first treatment-period (daily, 4 weeks). After a wash-out period (2 weeks), the patients received aprepritant in the second treatment-period (daily, 4 weeks).

    Primary: Primary efficacy endpoint of treatment-period 1 (PE1)

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    End point title
    		 Primary efficacy endpoint of treatment-period 1 (PE1) [1]
    End point description
    The PE1 was the intra-individual difference of the reported VAS (average itch during the past 24h, ranging from 0= "no itch" to 100="worst imaginable itch") at the beginning and at the end of the treatment-period 1. A negative PE1 therefore means an itch relief during treatment-period 1.
    End point type
    Primary
    End point timeframe
    The primary efficacy endpoint PE1 was measured in treatment-period 1.
    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: The primary efficacy analysis was conducted considering CROS(PE)=PE1-PE2.
    End point values
    		 Aprepritant in first period, placebo in second period Placebo in first period, aprepritant in second period
    Number of subjects analysed
    28
    25
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    -19.5 (-26.5 to 1.5)
    -21 (-33 to -1)
    No statistical analyses for this end point

    Primary: Primary efficacy endpoint of treatment-period 2 (PE2)

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    End point title
    		 Primary efficacy endpoint of treatment-period 2 (PE2) [2]
    End point description
    The PE2 was the intra-individual difference of the reported VAS (average itch during the past 24h, ranging from 0= "no itch" to 100="worst imaginable itch") at the beginning and at the end of the treatment-period 2. A negative PE2 therefore means an itch relief during treatment-period 2.
    End point type
    Primary
    End point timeframe
    The primary efficacy endpoint PE2 was measured in treatment-period 2.
    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: The primary efficacy analysis was conducted considering CROS(PE)=PE1-PE2.
    End point values
    		 Aprepritant in first period, placebo in second period Placebo in first period, aprepritant in second period
    Number of subjects analysed
    28
    22
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    -2 (-13.5 to 6)
    1.5 (-23 to 20)
    No statistical analyses for this end point

    Primary: CROS(PE)=PE1-PE2

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    End point title
    		 CROS(PE)=PE1-PE2
    End point description
    The primary efficacy analysis was conducted considering the intra-individual difference of PE1 and PE2, denoted as CROS (PE)= PE1 – PE2.
    End point type
    Primary
    End point timeframe
    CROS(PE) is the difference of PE1 and PE2, which were measured during treatment-period 1 and 2.
    End point values
    		 Aprepritant in first period, placebo in second period Placebo in first period, aprepritant in second period
    Number of subjects analysed
    28
    22
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    -10.5 (-35.5 to 9)
    -23.5 (-38 to 14)
    Statistical analysis title
    		 Primary efficacy analysis (Intention-to-Treat)
    Statistical analysis description
    For each patient, the intra-individual difference CROS(PE) = PE1 – PE2 was calculated. The two arms A (aprepitant in treatment-period 1, placebo in treatment-period 2) and B (placebo in treatment-period 1, aprepitant in treatment-period 2) were compared regarding CROS(PE) by a stratified Wilcoxon-Mann-Whitney test (van Elteren-test) on a two-sided significance level of 5% with strata defined by the patients’ atopic/non-atopic predisposition.
    Comparison groups
    Aprepritant in first period, placebo in second period v Placebo in first period, aprepritant in second period
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.742
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - This was an intention-to-treat analysis that was conducted considering all patients who were randomized (full-analysis set).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first Patient in until last Patient out.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Under aprepitant
    Reporting group description
    		 This reporting group includes all adverse events that occurred in patients in arm A during treatment-period 1 (under aprepitant) and during the wash-out period, and all adverse events that occurred in patients in arm B during and after treatment-period 2 (under aprepitant).

    Reporting group title
    Under placebo
    Reporting group description
    		 This reporting group includes all adverse events that occurred in patients in arm B during treatment-period 1 (under placebo) and during the wash-out period, and all adverse events that occurred in patients in arm A during and after treatment-period 2 (under placebo).

    Serious adverse events
    		 Under aprepitant Under placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Skin and subcutaneous tissue disorders
    Neurodermatitis
    Additional description: Exacerbation prurigo nodularis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Tonsillitis
    Additional description: Chronic tonsillitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Under aprepitant Under placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 54 (20.37%)
    13 / 54 (24.07%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 54 (5.56%)
         occurrences all number
    2
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 54 (1.85%)
         occurrences all number
    3
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 54 (11.11%)
    9 / 54 (16.67%)
         occurrences all number
    6
    9

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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