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    Clinical Trial Results:
    Topical Aprepitant in Prurigo Patients (iTAPP) An exploratory phase IIa trial with topically applied aprepitant in patients with prurigo

    Summary
    EudraCT number
    2013-000410-38
    Trial protocol
    DE  
    Global end of trial date
    28 Jul 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Feb 2016
    First version publication date
    22 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0066-1019
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01963793
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark,
    Public contact
    Clinical Trial Disclosure Manager, LEO Pharma A/S, 0045 44945888, ctr.disclosure@Leo-pharma.com
    Scientific contact
    Clinical Trial Disclosure Manager, LEO Pharma A/S, 0045 44945888, ctr.disclosure@Leo-pharma.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
    28 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of topical treatment with aprepitant on pruritus compared to placebo, after 4 weeks of treatment
    Protection of trial subjects
    n/a
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Nov 2013
    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
    Germany: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    18
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    23 subjects were enrolled in the trial and 3 were screening failures, the remaining 20 subjects were randomised.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject
    Blinding implementation details
    Subjects were treated with aprepitant on one extremity and vehicle gel on the other 1:1 thus acting as their own intra-individual controls 10 subjects: LEFT: aprepitant 10 mg/g gel , RIGHT: vehicle gel and 10 subjects: LEFT: vehicle gel RIGHT: aprepitant 10 mg/g gel

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Aprepitant 10 mg/g gel
    Arm description
    20 subjects treated with aprepitant 10mg/g gel on either left or right extremity
    Arm type
    Experimental

    Investigational medicinal product name
    Aprepitant 10mg/g gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects were treated with aprepitant 10mg/g gel twice daily for four weeks (28 days).

    Arm title
    Vehicle gel
    Arm description
    20 subjects were treated with vehicle gel on either left or right extremity
    Arm type
    Placebo

    Investigational medicinal product name
    Vehicle gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects were treated with vehicle gel twice daily for 4 weeks (28 days)

    Number of subjects in period 1
    Aprepitant 10 mg/g gel Vehicle gel
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    All 20 randomised subjects were divided into two groups 1:1 10 with LEFT: aprepitant 10 mg/g gel and RIGHT: vehicle gel and 10 with LEFT: vehicle gel and RIGHT: aprepitant 10 mg/g gel

    Reporting group values
    Overall trial Total
    Number of subjects
    20 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    18 18
        From 65-84 years
    2 2
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    62.8 (45 to 81) -
    Gender categorical
    Units: Subjects
        Female
    13 13
        Male
    7 7
    Duration of Prurigo
    Subjects' medical history of prurigo
    Units: Months
        arithmetic mean (full range (min-max))
    185 (14 to 816) -

    End points

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    End points reporting groups
    Reporting group title
    Aprepitant 10 mg/g gel
    Reporting group description
    20 subjects treated with aprepitant 10mg/g gel on either left or right extremity

    Reporting group title
    Vehicle gel
    Reporting group description
    20 subjects were treated with vehicle gel on either left or right extremity

    Primary: Comparison of subjects' VAS assessements of pruritus at end of treatment

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    End point title
    Comparison of subjects' VAS assessements of pruritus at end of treatment
    End point description
    Subjects' assessments of itch at end of treatment by use of a Visual Analogue Scale (VAS)
    End point type
    Primary
    End point timeframe
    1-28 days (4 weeks)
    End point values
    Aprepitant 10 mg/g gel Vehicle gel
    Number of subjects analysed
    20
    20
    Units: Intensity of itch
        least squares mean (confidence interval 95%)
    19.7 (9.5 to 29.8)
    21.2 (11.1 to 31.4)
    Statistical analysis title
    Subjects assessment of prutitus - end of treatment
    Statistical analysis description
    The primary efficacy endpoint was compared between areas treated with aprepitant and vehicle. According to the clinical study protocol the comparison was to be done by means of a paired t-test on change from baseline. Instead, a mixed model was applied because this method allows for the correct adjustment of baseline values and also utilises the benefits of the left-right design inherent in the paired t-test.
    Comparison groups
    Aprepitant 10 mg/g gel v Vehicle gel
    Number of subjects included in analysis
    40
    Analysis specification
    Post-hoc
    Analysis type
    other [1]
    P-value
    = 0.58
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.12
         upper limit
    4.11
    Notes
    [1] - For the analysis of the primary efficacy endpoint (VAS assessments of pruritus at end of treatment (Day 28) for areas treated with aprepitant and vehicle) a mixed model with treatment and baseline pruritus as fixed effects and subject as random effect was used.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire trial period (1-28 days)
    Adverse event reporting additional description
    The trial was conducted as left/right intra-individual control and thus the subjects acted as their own controls, so each subject appear twice in the reporting of adverse events (one for each treatment area) and adverse events deemed unrelated to treatment (e.g. outside treatment area) were designated "treatment not defined".
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Aprepitant gel
    Reporting group description
    10 subjects treated on the right extremity 10 subjects treated on the left extremity

    Reporting group title
    Vehicle gel
    Reporting group description
    Vehicle group: 10 subjects treated on the right extremity 10 subjects treated on the left extremity

    Reporting group title
    Treatment not defined
    Reporting group description
    This group was created to include adverse events that were deemed unrelated to treatment with either aprepitant gel or vehicle gel (e.g adverse events outside the treatment area)

    Serious adverse events
    Aprepitant gel Vehicle gel Treatment not defined
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Aprepitant gel Vehicle gel Treatment not defined
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 20 (55.00%)
    15 / 20 (75.00%)
    10 / 20 (50.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Surgical and medical procedures
    Wound treatment
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Sneezing
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Application site discolouration
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Application site discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    4
    3
    0
    Application site erythema
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    5
    6
    0
    Application site haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Application site nodule
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    2
    0
    Application site pain
         subjects affected / exposed
    8 / 20 (40.00%)
    11 / 20 (55.00%)
    0 / 20 (0.00%)
         occurrences all number
    36
    67
    0
    Application site paraesthesia
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    3
    0
    Application site pruritus
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    2
    0
    Application site urticaria
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    4
    5
    0
    Application site vesicles
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2
    Erythema
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    4
    Rash
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Skin burning sensation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    13
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Bursitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    2
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    0
    3
    Postoperative wound infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Wound infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0

    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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