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    Clinical Trial Results:
    A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose Finding and Efficacy Study of VPD-737 in the Treatment of Subjects with Chronic Pruritus

    Summary
    EudraCT number
    		 2014-001581-10
    Trial protocol
    		 IE  
    Global end of trial date
    02 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2022
    First version publication date
    29 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TCP-101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01951274
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tigercat Pharma, Inc.
    Sponsor organisation address
    4085 Campbell Avenue, Menlo Park, CA, United States, 94025
    Public contact
    Nooshin Azimi, PhD, Tigercat Pharma, Inc., +1 6507400343, nooshin@pvd.net
    Scientific contact
    Nooshin Azimi, PhD, Tigercat Pharma, Inc., +1 6507400343, nooshin@pvd.net
    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
    02 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the efficacy and safety of VPD-737 tablets (at concentrations of 0.25 mg, 1 mg, or 5 mg) and placebo given once daily for 6 weeks for the treatment of chronic pruritus.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki (and amendments), and in compliance with the approved protocol, the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 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
    United States: 257
    Worldwide total number of subjects
    257
    EEA total number of subjects
    0
    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)
    252
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in United States between 01 October 2013 and 02 December 2014.

    Pre-assignment
    Screening details
    		 The Screening period was from Day -44 to Day -1. Informed Consent Forms (ICF) were signed by the participants prior to screening procedures. All the study assessments were performed as per the Schedule of Assessments.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received oral Placebo tablet once daily for 6 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received oral Placebo tablet once daily for 6 weeks.

    Arm title
    		 VPD-737 0.25mg
    Arm description
    		 Participants received oral VPD-737 0.25 mg tablet once daily for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Serlopitant
    Investigational medicinal product code
    VPD-737
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one tablet per day taken orally at bedtime for 6 weeks.

    Arm title
    		 VPD-737 1mg
    Arm description
    		 Participants received oral VPD-737 1 mg tablet once daily for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Serlopitant
    Investigational medicinal product code
    VPD-737
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one tablet per day taken orally at bedtime for 6 weeks.

    Arm title
    		 VPD-737 5mg
    Arm description
    		 Participants received oral VPD-737 5 mg tablet once daily for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Serlopitant
    Investigational medicinal product code
    VPD-737
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one tablet per day taken orally at bedtime for 6 weeks.

    Number of subjects in period 1
    		Placebo VPD-737 0.25mg VPD-737 1mg VPD-737 5mg
    Started
    64
    64
    65
    64
    Completed
    55
    57
    56
    54
    Not completed
    9
    7
    9
    10
         Non-compliance with study
    1
    -
    -
    -
         Adverse event, non-fatal
    3
    -
    1
    1
         Other
    1
    1
    1
    -
         Lost to follow-up
    1
    2
    1
    2
         Withdrawal by subject
    3
    4
    5
    7
         Protocol deviation
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received oral Placebo tablet once daily for 6 weeks.

    Reporting group title
    VPD-737 0.25mg
    Reporting group description
    		 Participants received oral VPD-737 0.25 mg tablet once daily for 6 weeks.

    Reporting group title
    VPD-737 1mg
    Reporting group description
    		 Participants received oral VPD-737 1 mg tablet once daily for 6 weeks.

    Reporting group title
    VPD-737 5mg
    Reporting group description
    		 Participants received oral VPD-737 5 mg tablet once daily for 6 weeks.

    Reporting group values
    		 Placebo VPD-737 0.25mg VPD-737 1mg VPD-737 5mg Total
    Number of subjects
    		 64 64 65 64 257
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 64 64 63 61 252
        From 65-84 years
    		 0 0 2 3 5
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.48 ( 13.23 ) 45.09 ( 14.01 ) 42.49 ( 14.08 ) 42.94 ( 13.96 ) -
    Gender categorical
    Units: Subjects
        Female
    		 39 40 38 39 156
        Male
    		 25 24 27 25 101
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1 0 2
        Asian
    		 5 2 2 1 10
        Black or African American
    		 14 16 21 19 70
        Other
    		 2 2 3 1 8
        White
    		 43 43 38 43 167
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 12 18 17 11 58
        Not Hispanic or Latino
    		 52 46 48 53 199
    Atopic Diathesis
    Units: Subjects
        No
    		 42 40 37 37 156
        Yes
    		 22 24 28 27 101

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received oral Placebo tablet once daily for 6 weeks.

    Reporting group title
    VPD-737 0.25mg
    Reporting group description
    		 Participants received oral VPD-737 0.25 mg tablet once daily for 6 weeks.

    Reporting group title
    VPD-737 1mg
    Reporting group description
    		 Participants received oral VPD-737 1 mg tablet once daily for 6 weeks.

    Reporting group title
    VPD-737 5mg
    Reporting group description
    		 Participants received oral VPD-737 5 mg tablet once daily for 6 weeks.

    Primary: Percent change from baseline in visual analog scale (VAS) pruritus score

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    End point title
    		 Percent change from baseline in visual analog scale (VAS) pruritus score
    End point description
    Change from Baseline in VAS pruritus score was measured using a 10- point VAS scale (assessed using participants self-ratings of itch severity). The VAS ranged from no pruritus to worst pruritus on a continuous scale. The intent-to-treat (ITT) population included all randomized participants.
    End point type
    Primary
    End point timeframe
    At Week 6
    End point values
    		 Placebo VPD-737 0.25mg VPD-737 1mg VPD-737 5mg
    Number of subjects analysed
    54
    54
    55
    53
    Units: Change in Score
    least squares mean (standard error)
        Week 6
    -28.3 ( 4.1 )
    -34.1 ( 4.1 )
    -41.4 ( 4.0 )
    -42.5 ( 4.1 )
    Statistical analysis title
    		 Pairwise comparison of VPD-737 0.25mg and Placebo
    Comparison groups
    Placebo v VPD-737 0.25mg
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.309
    Method
    		 Linear Mixed Effect Model
    Parameter type
    		 Least square mean difference
    Point estimate
    5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 17.1
    Statistical analysis title
    		 Pairwise comparison of VPD-737 1mg and Placebo
    Comparison groups
    Placebo v VPD-737 1mg
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.022
    Method
    		 Linear Mixed Effect Model
    Parameter type
    		 Least square mean difference
    Point estimate
    13.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.9
         upper limit
    		 24.4
    Statistical analysis title
    		 Pairwise comparison of VPD-737 5mg and Placebo
    Comparison groups
    Placebo v VPD-737 5mg
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.013
    Method
    		 Linear Mixed Effect Model
    Parameter type
    		 Least square mean difference
    Point estimate
    14.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3
         upper limit
    		 25.5

    Secondary: Percent change from baseline in numeric rating scale (NRS) pruritus score

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    End point title
    		 Percent change from baseline in numeric rating scale (NRS) pruritus score
    End point description
    Change from Baseline in NRS pruritus score was measured using a 10- point NRS scale (assessed using participants self-ratings of itch severity). The NRS ranged from no pruritus to worst pruritus on a numerical scale from zero to ten. The intent-to-treat (ITT) population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    At Week 6
    End point values
    		 Placebo VPD-737 0.25mg VPD-737 1mg VPD-737 5mg
    Number of subjects analysed
    53
    52
    55
    52
    Units: Change in scores
    least squares mean (standard error)
        Week 6
    -28.7 ( 3.5 )
    -35.8 ( 3.5 )
    -39.4 ( 3.5 )
    -39.0 ( 3.5 )
    Statistical analysis title
    		 Pairwise comparison of VPD-737 0.25mg and Placebo
    Comparison groups
    Placebo v VPD-737 0.25mg
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.153
    Method
    		 Linear Mixed Effect Model
    Parameter type
    		 Least square mean difference
    Point estimate
    7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 16.9
    Statistical analysis title
    		 Pairwise comparison of VPD-737 1mg and Placebo
    Comparison groups
    Placebo v VPD-737 1mg
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.031
    Method
    		 Linear Mixed Effect Model
    Parameter type
    		 Least square mean difference
    Point estimate
    10.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 20.4
    Statistical analysis title
    		 Pairwise comparison of VPD-737 5mg and Placebo
    Comparison groups
    Placebo v VPD-737 5mg
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.038
    Method
    		 Linear Mixed Effect Model
    Parameter type
    		 Least square mean difference
    Point estimate
    10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 20.1

    Secondary: Dermatology Life Quality Index (DLQI) total score

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    End point title
    		 Dermatology Life Quality Index (DLQI) total score
    End point description
    DLQI is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a subject's QoL. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Scores range from 0 to 30 with higher scores indicating poor QoL. The intent-to-treat (ITT) population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    At Week 6
    End point values
    		 Placebo VPD-737 0.25mg VPD-737 1mg VPD-737 5mg
    Number of subjects analysed
    56
    58
    57
    55
    Units: Score
    least squares mean (standard error)
        Week 6
    20.6 ( 2.7 )
    14.9 ( 2.7 )
    13.7 ( 2.7 )
    16.4 ( 2.7 )
    Statistical analysis title
    		 Pairwise comparison of VPD-737 0.25mg and Placebo
    Comparison groups
    VPD-737 0.25mg v Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.138
    Method
    		 Linear Mixed Effect Model
    Parameter type
    		 Least square mean difference
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 13.1
    Statistical analysis title
    		 Pairwise comparison of VPD-737 1mg and Placebo
    Comparison groups
    Placebo v VPD-737 1mg
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.073
    Method
    		 Linear Mixed Effect Model
    Parameter type
    		 Least square mean difference
    Point estimate
    6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 14.3
    Statistical analysis title
    		 Pairwise comparison of VPD-737 5mg and Placebo
    Comparison groups
    Placebo v VPD-737 5mg
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.277
    Method
    		 Linear Mixed Effect Model
    Parameter type
    		 Linear Mixed Effect Model
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 11.7

    Secondary: Subject Global Assessment (SGA)

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    End point title
    		 Subject Global Assessment (SGA)
    End point description
    For SGA, the subjects were asked “In the past 24 hours, please describe your itching,” and their responses, rated as ‘none’, ‘mild’, ‘moderate’, or ‘severe’ were summarized descriptively. The intent-to-treat (ITT) population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    At Week 6
    End point values
    		 Placebo VPD-737 0.25mg VPD-737 1mg VPD-737 5mg
    Number of subjects analysed
    56
    58
    57
    55
    Units: Number of Participants
        None
    6
    13
    7
    13
        Mild Itching
    22
    21
    34
    22
        Moderate Itching
    17
    18
    11
    10
        Severe Itching
    11
    6
    5
    10
    Statistical analysis title
    		 Pairwise comparison of VPD-737 0.25mg and Placebo
    Comparison groups
    Placebo v VPD-737 0.25mg
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.258
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Pairwise comparison of VPD-737 1mg and Placebo
    Comparison groups
    Placebo v VPD-737 1mg
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.106
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Pairwise comparison of VPD-737 5mg and Placebo
    Comparison groups
    Placebo v VPD-737 5mg
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.222
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Physician Global Assessment

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    End point title
    		 Physician Global Assessment
    End point description
    Physicians Global Assessment asks physicians to rate change in lesions (if any) from plus 5 (“markedly improved”) to minus 5 (“markedly worse”). The intent-to-treat (ITT) population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    At Week 6
    End point values
    		 Placebo VPD-737 0.25mg VPD-737 1mg VPD-737 5mg
    Number of subjects analysed
    56
    58
    57
    55
    Units: Number of participants
        +5 markedly improved
    2
    7
    3
    3
        +4 largely improved
    2
    3
    7
    3
        +3 moderately to largely improved
    3
    2
    3
    2
        +2 moderately improved
    9
    8
    8
    8
        +1 mildly improved
    9
    5
    7
    6
        Baseline (no change)
    23
    25
    26
    28
        -1 mildly worse
    5
    6
    1
    3
        -2 moderately worse
    3
    0
    2
    1
        -3 moderately to largely worse
    0
    2
    0
    1
        -4 largely worse
    0
    0
    0
    0
        -5 markedly worse
    0
    0
    0
    0
    Statistical analysis title
    		 Pairwise comparison of VPD-737 0.25mg and Placebo
    Comparison groups
    Placebo v VPD-737 0.25mg
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.307
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Pairwise comparison of VPD-737 1mg and Placebo
    Comparison groups
    Placebo v VPD-737 1mg
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.508
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Pairwise comparison of VPD-737 5mg and Placebo
    Comparison groups
    Placebo v VPD-737 5mg
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.838
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Pittsburgh Sleep Symptom Questionnaire - Insomnia (PSSQ-I)

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    End point title
    		 Pittsburgh Sleep Symptom Questionnaire - Insomnia (PSSQ-I)
    End point description
    The PSSQ-I has 13 patient-rated questions, with three sub-scales, a sleep symptom criteria, duration criteria, and daytime impairment criteria. The instrument scoring produces a binary (1/0) outcome for each domain. The overall scoring of the domains results in a “total” score with values “insomnia disorder” or “No insomnia disorder”. The intent-to-treat (ITT) population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    At Week 6
    End point values
    		 Placebo VPD-737 0.25mg VPD-737 1mg VPD-737 5mg
    Number of subjects analysed
    56
    58
    57
    55
    Units: Number of participants
        Insomnia disorder
    16
    10
    6
    8
        No insomnia disorder
    40
    48
    51
    47
    Statistical analysis title
    		 Pairwise comparison of VPD-737 0.25mg and Placebo
    Comparison groups
    Placebo v VPD-737 0.25mg
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.151
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Pairwise comparison of VPD-737 1mg and Placebo
    Comparison groups
    Placebo v VPD-737 1mg
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.016
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Pairwise comparison of VPD-737 5mg and Placebo
    Comparison groups
    Placebo v VPD-737 5mg
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.074
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline (Day 1) up to early termination or follow-up visit (Week 10)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received oral Placebo tablet once daily for 6 weeks.

    Reporting group title
    VPD-737 0.25mg
    Reporting group description
    		 Participants received oral VPD-737 0.25 mg tablet once daily for 6 weeks.

    Reporting group title
    VPD-737 1mg
    Reporting group description
    		 Participants received oral VPD-737 1 mg tablet once daily for 6 weeks.

    Reporting group title
    VPD-737 5mg
    Reporting group description
    		 Participants received oral VPD-737 5 mg tablet once daily for 6 weeks.

    Serious adverse events
    		 Placebo VPD-737 0.25mg VPD-737 1mg VPD-737 5mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo VPD-737 0.25mg VPD-737 1mg VPD-737 5mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 63 (25.40%)
    21 / 64 (32.81%)
    23 / 65 (35.38%)
    24 / 64 (37.50%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    1
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    0
    1
    Oedema Peripheral
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    Allergy To Chemicals
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Hypersensitivity
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    1
    Nasal Congestion
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    0
    1
    Pulmonary Congestion
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sinus Congestion
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    0
    1
    Asthma
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Panic Attack
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood Triglycerides Increased
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Weight Increased
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    White Blood Cell Count Decreased
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 64 (1.56%)
    1 / 65 (1.54%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    3
    1
    Arthropod Bite
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Contusion
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rib Fracture
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Supraventricular Extrasystoles
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 64 (1.56%)
    3 / 65 (4.62%)
    3 / 64 (4.69%)
         occurrences all number
    1
    1
    3
    3
    Headache
         subjects affected / exposed
    4 / 63 (6.35%)
    1 / 64 (1.56%)
    3 / 65 (4.62%)
    1 / 64 (1.56%)
         occurrences all number
    4
    2
    3
    1
    Dizziness
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    0
    1
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Sedation
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Lymphatic Disorder
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    0
    1
    Eye Haemorrhage
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye Irritation
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    4 / 65 (6.15%)
    2 / 64 (3.13%)
         occurrences all number
    1
    0
    4
    4
    Dry mouth
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    2 / 65 (3.08%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Nausea
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    2 / 65 (3.08%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 64 (1.56%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Abdominal Discomfort
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Abdominal Distension
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Abdominal Pain
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal Pain
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    2
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 64 (3.13%)
    2 / 65 (3.08%)
    0 / 64 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Eczema
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Perivascular dermatitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Post Inflammatory Pigmentation Chang
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 64 (3.13%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    2 / 65 (3.08%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Costochondritis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle Spasms
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Neck Pain
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Pain In Extremity
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 63 (3.17%)
    2 / 64 (3.13%)
    3 / 65 (4.62%)
    0 / 64 (0.00%)
         occurrences all number
    2
    2
    3
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 63 (3.17%)
    3 / 64 (4.69%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    2
    3
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 64 (1.56%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    2
    0
    0
    2
    Candidiasis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Staphylococcal Bacteraemia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Tooth Abscess
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tooth Infection
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vaginitis Bacterial
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gout
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    0
    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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