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    Clinical Trial Results:
    A Double-Blind, Randomized, Multi-Center, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Dose of a 500-mg Chewable Tablet of Mebendazole in the Treatment of Soil-Transmitted Helminth Infestations (Ascaris lumbricoides and Trichuris trichiura) in Pediatric Subjects

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2016-000728-24
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    03 Sep 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Jul 2016
    First version publication date
    28 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MEBENDAZOLGAI3003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02034162
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 US Route , Raritan, New Jersey, United States, 202
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    03 Sep 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to compare the efficacy and safety of a single dose of a 500 milligram (mg) chewable mebendazole tablet with placebo in treatment of Ascaris lumbricoides and Trichuris trichiura infestations in pediatric subjects.
    Protection of trial subjects
    Safety evaluations included monitoring of adverse events (AEs), vital signs measurements, physical examinations including height and weight measurements, and body mass index (BMI) calculations. An Independent Data Monitoring Committee (IDMC) was established to ensure the safety of subjects.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ethiopia: 255
    Country: Number of subjects enrolled
    Rwanda: 40
    Worldwide total number of subjects
    295
    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)
    14
    Children (2-11 years)
    250
    Adolescents (12-17 years)
    31
    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
    The study was conducted from 8-Dec-2014 to 3-Sep-2015. A total of 295 subjects were enrolled and randomly assigned to study treatment; 278 subjects completed the study. Of the 295 subjects, 167 subjects were reported with Ascaris lumbricoides infestation and 243 subjects were reported with Trichuris trichiura infestation.

    Pre-assignment
    Screening details
    Of the 792 subjects screened, a total of 295 were randomly assigned to study treatments, of which 278 completed the study. 10 subjects had major protocol deviations. 9 subjects did not meet the inclusion/exclusion criteria and 1 subject was reported with wasting at Visits 3 and 5 (without any evidence of wasting at screening).

    Period 1
    Period 1 title
    Double-blind Phase
    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
    Mebendazole 500 mg
    Arm description
    Subjects received a single 500-mg chewable tablet of Mebendazole in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
    Arm type
    Experimental

    Investigational medicinal product name
    Mebendazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single 500-mg chewable tablet of Mebendazole in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).

    Arm title
    Placebo
    Arm description
    Subjects received matching placebo as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received matching placebo as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).

    Number of subjects in period 1
    Mebendazole 500 mg Placebo
    Started
    149
    146
    Completed
    141
    137
    Not completed
    8
    9
         Protocol deviation
    1
    -
         Physician decision
    -
    1
         Withdrawal by subject
    7
    5
         Lost to follow-up
    -
    3
    Period 2
    Period 2 title
    Open-label Phase
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Mebendazole 500 mg
    Arm description
    Subjects received Mebendazole 500-mg chewable tablet in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
    Arm type
    Experimental

    Investigational medicinal product name
    Mebendazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Mebendazole 500-mg chewable tablet in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).

    Number of subjects in period 2
    Mebendazole 500 mg
    Started
    278
    Completed
    278

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mebendazole 500 mg
    Reporting group description
    Subjects received a single 500-mg chewable tablet of Mebendazole in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).

    Reporting group values
    Mebendazole 500 mg Placebo Total
    Number of subjects
    149 146 295
    Title for AgeCategorical
    Units: subjects
        infants and toddlers(28 days-23 months)
    7 7 14
        Children (2-11 years)
    124 126 250
        Adolescents (12-17 years)
    18 13 31
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    7.9 ± 3.27 7.7 ± 3.09 -
    Title for Gender
    Units: subjects
        Female
    78 74 152
        Male
    71 72 143

    End points

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    End points reporting groups
    Reporting group title
    Mebendazole 500 mg
    Reporting group description
    Subjects received a single 500-mg chewable tablet of Mebendazole in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
    Reporting group title
    Mebendazole 500 mg
    Reporting group description
    Subjects received Mebendazole 500-mg chewable tablet in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).

    Subject analysis set title
    Group 1 (1 to <3 years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Group 1 represents pharmacokinetic analysis set which included subjects with age group 1 to less than (<) 3 years.

    Subject analysis set title
    Group 2 (3 to 6 years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Group 2 represents pharmacokinetic analysis set which included subjects with age group 3 to 6 years.

    Subject analysis set title
    Group 3 (7 to 16 years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Group 3 represents pharmacokinetic analysis set which included subjects with age group 7 to 16 years.

    Primary: Cure Rate for Ascaris lumbricoides at the End of Double-blind Treatment Period

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    End point title
    Cure Rate for Ascaris lumbricoides at the End of Double-blind Treatment Period
    End point description
    Cure is defined as a post-treatment egg count of zero in subjects who had a positive egg count at baseline. The intent-to-treat (ITT) analysis set included all randomized subjects with a pretreatment stool sample positive for 1 or more worms of interest.
    End point type
    Primary
    End point timeframe
    At Visit 3 (Day 19) of Double-blind treatment period
    End point values
    Mebendazole 500 mg Placebo
    Number of subjects analysed
    86 [1]
    81 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    83.7 (74.2 to 90.8)
    11.1 (5.2 to 20.1)
    Notes
    [1] - Here 'N' signifies number of subjects analysed for this outcome measure.
    [2] - Here 'N' signifies number of subjects analysed for this outcome measure.
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Mebendazole 500 mg v Placebo
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Primary: Cure Rate for Trichuris trichiura at the End of Double-blind Treatment Period

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    End point title
    Cure Rate for Trichuris trichiura at the End of Double-blind Treatment Period
    End point description
    Cure is defined as a post-treatment egg count of zero in subjects who had a positive egg count at baseline. The ITT analysis set included all randomized subjects with a pretreatment stool sample positive for 1 or more worms of interest.
    End point type
    Primary
    End point timeframe
    At Visit 3 (Day 19) of Double-blind treatment period
    End point values
    Mebendazole 500 mg Placebo
    Number of subjects analysed
    124 [3]
    119 [4]
    Units: percentage of participants
        number (confidence interval 95%)
    33.9 (25.6 to 42.9)
    7.6 (3.5 to 13.9)
    Notes
    [3] - Here 'N' signifies number of subjects analysed for this outcome measure.
    [4] - Here 'N' signifies number of subjects analysed for this outcome measure.
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    Mebendazole 500 mg v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Primary: Number of Subjects Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period

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    End point title
    Number of Subjects Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period [5]
    End point description
    The safety analysis set consisted of all randomized subjects who received 1 dose of study agent (mebendazole or placebo) at baseline. An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Primary
    End point timeframe
    Up to Visit 3 (Day 19 +/-2)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed for this outcome measure.
    End point values
    Mebendazole 500 mg Placebo
    Number of subjects analysed
    144 [6]
    140 [7]
    Units: subjects
    9
    8
    Notes
    [6] - Here 'N' signifies number of subjects analysed for this endpoint.
    [7] - Here 'N' signifies number of subjects analysed for this endpoint.
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period

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    End point title
    Number of Subjects Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period [8]
    End point description
    An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The open-label follow-up safety analysis set consisted of all randomized subjects who received a 500-mg chewable tablet of mebendazole at Visit 3.
    End point type
    Primary
    End point timeframe
    At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3)
    Notes
    [8] - 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: Statistical analysis was not performed for this outcome measure.
    End point values
    Mebendazole 500 mg
    Number of subjects analysed
    278
    Units: subjects
    7
    No statistical analyses for this end point

    Secondary: Egg Count Reduction Rate for Ascaris lumbricoides Infestation at the End of Double-blind Treatment Period

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    End point title
    Egg Count Reduction Rate for Ascaris lumbricoides Infestation at the End of Double-blind Treatment Period
    End point description
    Percent egg count reduction is defined as count of eggs at end of treatment period minus egg count at baseline divided by egg count at baseline. The ITT analysis set included all randomized subjects with a pretreatment stool sample positive for Ascaris lumbricoides.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period
    End point values
    Mebendazole 500 mg Placebo
    Number of subjects analysed
    86 [9]
    81 [10]
    Units: percent change in egg count
        number (not applicable)
    -97.9
    -19.2
    Notes
    [9] - Here 'N' signifies number of subjects analysed for this outcome measure.
    [10] - Here 'N' signifies number of subjects analysed for this outcome measure.
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    Mebendazole 500 mg v Placebo
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Confidence interval

    Secondary: Egg Count Reduction Rate for Trichuris trichiura Infestation at the End of Double-blind Treatment Period

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    End point title
    Egg Count Reduction Rate for Trichuris trichiura Infestation at the End of Double-blind Treatment Period
    End point description
    Percent egg count reduction is defined as count of eggs at end of treatment period minus egg count at baseline divided by egg count at baseline. The ITT analysis set included all randomized subjects with a pretreatment stool sample positive for Trichuris trichiura.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period
    End point values
    Mebendazole 500 mg Placebo
    Number of subjects analysed
    124 [11]
    119 [12]
    Units: percent change in egg count
        number (not applicable)
    -59.7
    -10.5
    Notes
    [11] - Here 'N' signifies number of subjects analysed for this outcome measure.
    [12] - Here 'N' signifies number of subjects analysed for this outcome measure.
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    Mebendazole 500 mg v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Confidence interval

    Secondary: Maximum Plasma Concentration (Cmax) of Mebendazole

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    End point title
    Maximum Plasma Concentration (Cmax) of Mebendazole
    End point description
    The Cmax is the maximum plasma concentration. Pharmacokinetic (PK) population included all randomized subjects who received at least 1 dose of the study drug and had valid pharmacokinetic profile.
    End point type
    Secondary
    End point timeframe
    Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4
    End point values
    Group 1 (1 to <3 years) Group 2 (3 to 6 years) Group 3 (7 to 16 years)
    Number of subjects analysed
    22
    12
    10
    Units: nanogram per Milliliters (ng/mL)
        arithmetic mean (standard deviation)
    210 ± 212
    49.9 ± 26.8
    34.2 ± 13.8
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole

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    End point title
    Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole
    End point description
    The Tmax is time to reach the maximum plasma concentration. PK population included all randomized subjects who received at least 1 dose of the study drug and had valid pharmacokinetic profile.
    End point type
    Secondary
    End point timeframe
    Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4
    End point values
    Group 1 (1 to <3 years) Group 2 (3 to 6 years) Group 3 (7 to 16 years)
    Number of subjects analysed
    22
    12
    10
    Units: hour (h)
        median (full range (min-max))
    2.5 (1 to 8)
    2 (0.98 to 3)
    3 (1 to 8)
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Medendazole

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    End point title
    Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Medendazole
    End point description
    The (AUC8h) is the area under the plasma concentration-time curve from time 0 to 8 hours Post-dose. PK population included all randomized subjects who received at least 1 dose of the study drug and had valid pharmacokinetic profile.
    End point type
    Secondary
    End point timeframe
    Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4
    End point values
    Group 1 (1 to <3 years) Group 2 (3 to 6 years) Group 3 (7 to 16 years)
    Number of subjects analysed
    21 [13]
    9 [14]
    10
    Units: nanogram hour per Milliliters(ng*h/mL)
        arithmetic mean (standard deviation)
    697 ± 367
    242 ± 139
    182 ± 66.3
    Notes
    [13] - Here "N" signifies number of subjects analysed for this endpoint.
    [14] - Here "N" signifies number of subjects analysed for this endpoint.
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole

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    End point title
    Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole
    End point description
    The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. PK population included all randomized subjects who received at least 1 dose of the study drug and had valid pharmacokinetic profile.
    End point type
    Secondary
    End point timeframe
    Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4
    End point values
    Group 1 (1 to <3 years) Group 2 (3 to 6 years) Group 3 (7 to 16 years)
    Number of subjects analysed
    22
    12
    10
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    1320 ± 844
    416 ± 215
    387 ± 190
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to visit 5 (Day 26, 7+/-1 days after Visit 3)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Double-blind/Mebendazole 500 mg
    Reporting group description
    Subjects received a single 500-mg chewable tablet of Mebendazole in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).

    Reporting group title
    Open-label/Mebendazole 500 mg
    Reporting group description
    Subjects received Mebendazole 500-mg chewable tablet in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).

    Reporting group title
    Double-blind/Placebo
    Reporting group description
    Subjects received matching placebo as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).

    Serious adverse events
    Double-blind/Mebendazole 500 mg Open-label/Mebendazole 500 mg Double-blind/Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 278 (0.00%)
    0 / 140 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Double-blind/Mebendazole 500 mg Open-label/Mebendazole 500 mg Double-blind/Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 144 (6.25%)
    7 / 278 (2.52%)
    8 / 140 (5.71%)
    Injury, poisoning and procedural complications
    Soft Tissue Injury
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 278 (0.36%)
    0 / 140 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 278 (0.00%)
    2 / 140 (1.43%)
         occurrences all number
    1
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 278 (0.36%)
    0 / 140 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Night Blindness
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 278 (0.00%)
    1 / 140 (0.71%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    2 / 144 (1.39%)
    0 / 278 (0.00%)
    1 / 140 (0.71%)
         occurrences all number
    2
    0
    1
    Abdominal Pain
         subjects affected / exposed
    1 / 144 (0.69%)
    1 / 278 (0.36%)
    1 / 140 (0.71%)
         occurrences all number
    1
    2
    1
    Diarrhoea
         subjects affected / exposed
    0 / 144 (0.00%)
    2 / 278 (0.72%)
    0 / 140 (0.00%)
         occurrences all number
    0
    2
    0
    Vomiting
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 278 (0.36%)
    0 / 140 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 278 (0.36%)
    0 / 140 (0.00%)
         occurrences all number
    0
    1
    0
    Rash Pruritic
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 278 (0.00%)
    0 / 140 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Vitamin A Deficiency
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 278 (0.00%)
    0 / 140 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 278 (0.00%)
    1 / 140 (0.71%)
         occurrences all number
    0
    0
    1
    Conjunctivitis Bacterial
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 278 (0.00%)
    1 / 140 (0.71%)
         occurrences all number
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 278 (0.00%)
    0 / 140 (0.00%)
         occurrences all number
    1
    0
    0
    Malaria
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 278 (0.36%)
    0 / 140 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 278 (0.00%)
    2 / 140 (1.43%)
         occurrences all number
    1
    0
    2
    Pneumonia
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 278 (0.36%)
    0 / 140 (0.00%)
         occurrences all number
    0
    1
    0
    Tinea Infection
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 278 (0.00%)
    0 / 140 (0.00%)
         occurrences all number
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 278 (0.00%)
    1 / 140 (0.71%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2014
    This Amendment 4 included addition of information on additional collection of 2 venous blood samples (2.0 milliliters [mL] each) at 3- and 24-hour timepoints post-treatment for pharmacokinetic (PK) sampling (PK substudy) of 10 subjects in 7 to 16 years age group and collection of a back-up capillary PK sample at each timepoint (total of 14 samples) from each subject in the PK substudy.

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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