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    Clinical Trial Results:
    A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery

    Summary
    EudraCT number
    		 2008-003178-17
    Trial protocol
    		 ES   FI   Outside EU/EEA  
    Global end of trial date
    12 Mar 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    0869-148
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00819039
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 MK-0869-148: Merck protocol number
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000144-PIP01-07
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Mar 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This two-part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic parameters and monitoring safety and tolerability of administered doses. Part 1 will be an open label investigation of a single dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after aprepitant dosing. Part 2 will be a double blind trial of participants randomized to receive either aprepitant or ondansetron.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measure defined for this individual study was in place for the protection of trial subjects: Administration of post-surgery "rescue therapy" was to be allowed throughout the study for established nausea or vomiting. Recommended rescue medications were: 5-HT3 antagonists, phenothiazines, butyrophenones, benzamides, corticosteroids, benzodiazepines, and domperidone.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jan 2009
    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
    Brazil: 20
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    Russian Federation: 3
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    Turkey: 30
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    98
    EEA total number of subjects
    37
    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)
    27
    Children (2-11 years)
    47
    Adolescents (12-17 years)
    24
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants aged 6 months to 17 years who were scheduled to undergo surgery which would require a minimum post-surgical hospital stay of 48 hours for Part 1 and of 24 hours for Part 2 were screened for this study.

    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
    		 Investigator, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 1: Oral Aprepitant
    Arm description
    		 In Study Part 1, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on body surface area (BSA) up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of post-operative nausea and vomiting (PONV).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aprepitant
    Investigational medicinal product code
    Other name
    MK-0869, EMEND®
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    In Part 1 on Day 1, participants aged 6 months to <12 years received a single dose of oral aprepitant based on body surface area (BSA) up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants age 12 years to 17 years received an equivalent adult dose of oral aprepitant for PONV (40 mg).

    Arm title
    		 Part 2: Oral Aprepitant
    Arm description
    		 In Study Part 2, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on BSA up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of PONV.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aprepitant
    Investigational medicinal product code
    Other name
    MK-0869, EMEND®
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    In Part 1 on Day 1, participants aged 6 months to <12 years received a single dose of oral aprepitant based on body surface area (BSA) up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants age 12 years to 17 years received an equivalent adult dose of oral aprepitant for PONV (40 mg).

    Arm title
    		 Part 2: Intravenous Ondansetron
    Arm description
    		 In Study Part 2 on Day 1, participants aged 6 months to 17 years received a single intravenous dose of ondansetron based on participant weight for the control of PONV.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    Other name
    ZOFRAN®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received a single dose of intravenous ondansetron based on participant weight on Day 1

    Number of subjects in period 1
    		Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
    Started
    46
    27
    25
    Completed
    44
    27
    24
    Not completed
    2
    0
    1
         Physician decision
    1
    -
    1
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: Oral Aprepitant
    Reporting group description
    		 In Study Part 1, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on body surface area (BSA) up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of post-operative nausea and vomiting (PONV).

    Reporting group title
    Part 2: Oral Aprepitant
    Reporting group description
    		 In Study Part 2, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on BSA up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of PONV.

    Reporting group title
    Part 2: Intravenous Ondansetron
    Reporting group description
    		 In Study Part 2 on Day 1, participants aged 6 months to 17 years received a single intravenous dose of ondansetron based on participant weight for the control of PONV.

    Reporting group values
    		 Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron Total
    Number of subjects
    		 46 27 25 98
    Age, Customized
    Units: Participants
        0.5 to <2 years
    		 14 8 5 27
        2 to <6 years
    		 11 7 7 25
        6 to <12 years
    		 11 5 6 22
        12 to 17 years
    		 10 7 7 24
    Gender, Male/Female
    Units: Participants
        Female
    		 13 6 12 31
        Male
    		 33 21 13 67

    End points

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    End points reporting groups
    Reporting group title
    Part 1: Oral Aprepitant
    Reporting group description
    		 In Study Part 1, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on body surface area (BSA) up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of post-operative nausea and vomiting (PONV).

    Reporting group title
    Part 2: Oral Aprepitant
    Reporting group description
    		 In Study Part 2, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on BSA up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of PONV.

    Reporting group title
    Part 2: Intravenous Ondansetron
    Reporting group description
    		 In Study Part 2 on Day 1, participants aged 6 months to 17 years received a single intravenous dose of ondansetron based on participant weight for the control of PONV.

    Subject analysis set title
    Part 2: Oral Aprepitant
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In Study Part 2 on Day 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the control of PONV.

    Primary: Area Under the Curve From 0-48 Hours (AUC0-48 hr) of Aprepitant Following a Single Oral Dose in Study Part 1

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    End point title
    		 Area Under the Curve From 0-48 Hours (AUC0-48 hr) of Aprepitant Following a Single Oral Dose in Study Part 1 [1] [2]
    End point description
    Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 hr at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose
    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: No statistical analyses were planned for this end point.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic (PK) analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study.
    End point values
    		 Part 1: Oral Aprepitant
    Number of subjects analysed
    39 [3]
    Units: hr*ug/ml
    arithmetic mean (standard deviation)
        6 months to <2 years (n=10)
    5.97 ( 4.44 )
        2 years to <6 years (n=8)
    4.76 ( 3.55 )
        6 years to <12 years (n=11)
    6.16 ( 2.27 )
        12 years to 17 years (n=10)
    6.01 ( 2.53 )
    Notes
    [3] - All participants who received ≥1 dose of study drug and for whom AUC0-48 hr data were available.
    No statistical analyses for this end point

    Primary: Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1

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    End point title
    		 Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1 [4] [5]
    End point description
    Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.
    End point type
    Primary
    End point timeframe
    Up to 48 hours post-dose
    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: No statistical analyses were planned for this end point.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study.
    End point values
    		 Part 1: Oral Aprepitant
    Number of subjects analysed
    43 [6]
    Units: ng/mL
    arithmetic mean (standard deviation)
        6 months to <2 years (n=11)
    715 ( 445 )
        2 years to <6 years (n=11)
    586 ( 462 )
        6 years to <12 years (n=11)
    913 ( 294 )
        12 years to 17 years (n=10)
    520 ( 230 )
    Notes
    [6] - All participants who received ≥1 dose of study drug and for whom Cmax data were available.
    No statistical analyses for this end point

    Primary: Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1

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    End point title
    		 Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1 [7] [8]
    End point description
    Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.
    End point type
    Primary
    End point timeframe
    Up to 48 hours post-dose
    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: No statistical analyses were planned for this end point.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study.
    End point values
    		 Part 1: Oral Aprepitant
    Number of subjects analysed
    43 [9]
    Units: Hours
    median (full range (min-max))
        6 months to <2 years (n=11)
    3 (1 to 8)
        2 years to <6 years (n=11)
    3 (1.03 to 12)
        6 years to <12 years (n=11)
    2 (1 to 8)
        12 years to 17 years (n=10)
    3.5 (1 to 11.98)
    Notes
    [9] - All participants who received ≥1 dose of study drug and for whom Tmax data were available.
    No statistical analyses for this end point

    Primary: Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1

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    End point title
    		 Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1 [10] [11]
    End point description
    Blood samples were collected from participants for the analysis of C24 hr at 24 hours after dosing.
    End point type
    Primary
    End point timeframe
    24 hours post-dose
    Notes
    [10] - 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: No statistical analyses were planned for this end point.
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study.
    End point values
    		 Part 1: Oral Aprepitant
    Number of subjects analysed
    42 [12]
    Units: ng/mL
    arithmetic mean (standard deviation)
        6 months to <2 years (n=11)
    31 ( 39.5 )
        2 years to <6 years (n=11)
    58.6 ( 54.3 )
        6 years to <12 years (n=9)
    51.1 ( 35.6 )
        12 years to 17 years (n=10)
    81.1 ( 59.8 )
    Notes
    [12] - All participants who received ≥1 dose of study drug and for whom C24 hr data were available.
    No statistical analyses for this end point

    Primary: Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1

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    End point title
    		 Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1 [13] [14]
    End point description
    The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single aprepitant oral dose. C48 hr values entered as zero (0) indicate that the mean and standard deviation were not reported since >50% of the measurements were below the lower level of quantitation (LLOQ).
    End point type
    Primary
    End point timeframe
    48 hours post-dose
    Notes
    [13] - 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: PK analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study.
    End point values
    		 Part 1: Oral Aprepitant
    Number of subjects analysed
    41 [15]
    Units: ng/mL
    arithmetic mean (standard deviation)
        6 months to <2 years (n=11)
    0 ( 0 )
        2 years to <6 years (n=9)
    0 ( 0 )
        6 years to <12 years (n=11)
    0 ( 0 )
        12 years to 17 years (n=10)
    7.25 ( 8.9 )
    Notes
    [15] - All participants who received ≥1 dose of study drug and for whom C48 hr data were available.
    No statistical analyses for this end point

    Primary: Number of Participants Experiencing Adverse Events (AEs)

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    End point title
    		 Number of Participants Experiencing Adverse Events (AEs)
    End point description
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE.
    End point type
    Primary
    End point timeframe
    Up to 21 days post-surgery
    End point values
    		 Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
    Number of subjects analysed
    46 [16]
    27 [17]
    25 [18]
    Units: Participants
        number (not applicable)
    20
    12
    7
    Notes
    [16] - Participants who received ≥1 dose of study drug.
    [17] - Participants who received ≥1 dose of study drug.
    [18] - Participants who received ≥1 dose of study drug.
    Statistical analysis title
    		 Treatment Comparison - Part 2
    Statistical analysis description
    The treatment difference and 95% confidence interval (CI) between the aprepitant and ondansetron groups in Part 2 were calculated. The 95% CI was based on the Chan and Zhang method for difference in proportions of participants who experienced one or more AEs between aprepitant and ondansetron.
    Comparison groups
    Part 2: Oral Aprepitant v Part 2: Intravenous Ondansetron
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    16.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.6
         upper limit
    		 42
    Notes
    [19] - Estimation

    Primary: Number of Participants Discontinuing Study Drug Due to AEs

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    End point title
    		 Number of Participants Discontinuing Study Drug Due to AEs [20]
    End point description
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE.
    End point type
    Primary
    End point timeframe
    Day 1
    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: No statistical analyses were performed on the number of participants discontinuing study drug due to an AE since no particpants in any treatment group discontinued study drug due to an AE.
    End point values
    		 Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
    Number of subjects analysed
    46 [21]
    27 [22]
    25 [23]
    Units: Participants
        number (not applicable)
    0
    0
    0
    Notes
    [21] - Participants who received ≥1 dose of study drug.
    [22] - Participants who received ≥1 dose of study drug.
    [23] - Participants who received ≥1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2

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    End point title
    		 Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2 [24]
    End point description
    No vomiting was defined as no emesis or retching or dry heaves (regardless of rescue therapy). The number of participants who experienced no vomiting up to 24 hours post-surgery is reported.
    End point type
    Secondary
    End point timeframe
    Up to 24 hours post-surgery
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Efficacy analyses were only conducted in Part 2 of this study. No efficacy analyses were conducted in Part 1 of this study.
    End point values
    		 Part 2: Intravenous Ondansetron Part 2: Oral Aprepitant
    Number of subjects analysed
    25 [25]
    25 [26]
    Units: Participants
        number (not applicable)
    20
    20
    Notes
    [25] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment.
    [26] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment.
    No statistical analyses for this end point

    Secondary: Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2

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    End point title
    		 Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2 [27]
    End point description
    Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.
    End point type
    Secondary
    End point timeframe
    Up to 24 hours post-surgery
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Efficacy analyses were only conducted in Part 2 of this study. No efficacy analyses were conducted in Part 1 of this study.
    End point values
    		 Part 2: Intravenous Ondansetron Part 2: Oral Aprepitant
    Number of subjects analysed
    25 [28]
    25 [29]
    Units: Participants
        number (not applicable)
    20
    19
    Notes
    [28] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment.
    [29] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment.
    No statistical analyses for this end point

    Secondary: Number of Participants With No Vomiting Up to 48 Hours Following Surgery in Study Part 2

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    End point title
    		 Number of Participants With No Vomiting Up to 48 Hours Following Surgery in Study Part 2 [30]
    End point description
    No vomiting was defined as no emesis or retching or dry heaves (regardless of rescue therapy). The number of participants who experienced no vomiting up to 48 hours post-surgery is reported.
    End point type
    Secondary
    End point timeframe
    Up to 48 hours post-surgery
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Efficacy analyses were only conducted in Part 2 of this study. No efficacy analyses were conducted in Part 1 of this study.
    End point values
    		 Part 2: Intravenous Ondansetron Part 2: Oral Aprepitant
    Number of subjects analysed
    25 [31]
    25 [32]
    Units: Participants
        number (not applicable)
    20
    18
    Notes
    [31] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment.
    [32] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment.
    No statistical analyses for this end point

    Secondary: Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2

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    End point title
    		 Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2 [33]
    End point description
    Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.
    End point type
    Secondary
    End point timeframe
    Up to 48 hours post-surgery
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Efficacy analyses were only conducted in Part 2 of this study. No efficacy analyses were conducted in Part 1 of this study.
    End point values
    		 Part 2: Intravenous Ondansetron Part 2: Oral Aprepitant
    Number of subjects analysed
    25 [34]
    25 [35]
    Units: Participants
        number (not applicable)
    20
    17
    Notes
    [34] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment.
    [35] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment.
    No statistical analyses for this end point

    Secondary: Number of Participants With Vomiting Frequency in Study Part 2

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    End point title
    		 Number of Participants With Vomiting Frequency in Study Part 2 [36]
    End point description
    A vomiting episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that was not productive of stomach contents also referred to as dry heaves). Distinct episodes were, by definition, separated by the absence of vomiting and retching for at least 1 minute.
    End point type
    Secondary
    End point timeframe
    Up to 24 hours post-surgery
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Efficacy analyses were only conducted in Part 2 of this study. No efficacy analyses were conducted in Part 1 of this study.
    End point values
    		 Part 2: Intravenous Ondansetron Part 2: Oral Aprepitant
    Number of subjects analysed
    25 [37]
    25 [38]
    Units: Participants
    number (not applicable)
        No Vomiting
    20
    20
        1 Vomiting Episode
    3
    5
        2 Vomiting Episodes
    1
    0
        3 Vomiting Episodes
    0
    0
        >3 Vomiting Episodes
    1
    0
    Notes
    [37] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment.
    [38] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 21 post-surgery
    Adverse event reporting additional description
    The population consisted of all study participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Part 2: Oral Aprepitant
    Reporting group description
    		 In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of PONV on Day 1.

    Reporting group title
    Part 1: Oral Aprepitant
    Reporting group description
    		 In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of PONV on Day 1.

    Reporting group title
    Part 2: Intravenous Ondansetron
    Reporting group description
    		 In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of PONV on Day 1.

    Serious adverse events
    		 Part 2: Oral Aprepitant Part 1: Oral Aprepitant Part 2: Intravenous Ondansetron
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 46 (6.52%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Anastomotic Complication
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 46 (2.17%)
    0 / 25 (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
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 46 (0.00%)
    0 / 25 (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
    Incision Site Infection
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 46 (4.35%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part 2: Oral Aprepitant Part 1: Oral Aprepitant Part 2: Intravenous Ondansetron
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 27 (18.52%)
    14 / 46 (30.43%)
    4 / 25 (16.00%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 46 (6.52%)
    2 / 25 (8.00%)
         occurrences all number
    0
    3
    2
    Chest Pain
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 46 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    2
    0
    2
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 46 (6.52%)
    0 / 25 (0.00%)
         occurrences all number
    3
    4
    0
    Vomiting
         subjects affected / exposed
    1 / 27 (3.70%)
    10 / 46 (21.74%)
    0 / 25 (0.00%)
         occurrences all number
    5
    20
    0
    Nausea
         subjects affected / exposed
    0 / 27 (0.00%)
    4 / 46 (8.70%)
    0 / 25 (0.00%)
         occurrences all number
    0
    6
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Nov 2012
    Amendment 01: Per request of the United States Food and Drug Administration (US FDA), due to changes in the ondansetron label, expanded safety monitoring was implemented to include additional vital sign and electrolyte monitoring in all participants receiving ondansetron and post-dose electrocardiogram (ECG) for those participants with baseline electrolyte abnormalities. Another main change included: Participants may be discharged prior to 48 hours following the end of surgery. For these participants, the parent/guardian was required to record any vomiting episodes, use of rescue medication, use of pain medication, and/or adverse events from the time of discharge through 48 hours following the end of surgery. Site staff were to contact the participants/parent/guardian at 48 hours following the end of surgery to assess the occurrence of these events.

    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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