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    Clinical Trial Results:
    An Open-Label, Single-Dose Study to Assess the Safety of 500- mg Mebendazole Chewable Formulation in Children 2 to 10 Years of Age, Inclusive

    Summary
    EudraCT number
    		 2015-001226-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Mar 2010

    Results information
    Results version number
    		 v1
    This version publication date
    06 Jul 2016
    First version publication date
    05 Aug 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    MEBENDAZOLGAI3002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01173562
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Johnson & Johnson Pharmaceutical Research & Development
    Sponsor organisation address
    Turnhoutseweg 30, 2340 Beerse, Belgium,
    Public contact
    Clinical Registry Group-JB BV, Johnson & Johnson Pharmaceutical Research & Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group-JB BV, Johnson & Johnson Pharmaceutical Research & Development, 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
    12 Mar 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of a mebendazole 500-mg chewable tablet formulation in a pediatric population (children 2 to 10 years of age, inclusive).
    Protection of trial subjects
    The safety assessments included Adverse events, vital sign measurements (axillary temperature, pulse, respiratory rate, and Blood Pressure [BP]) and Physical examinations (including height and body weight).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Feb 2010
    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
    Tanzania, United Republic of: 396
    Worldwide total number of subjects
    396
    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)
    396
    Adolescents (12-17 years)
    0
    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
    		 A total of 396 participants were enrolled and treated with a Single dose of Mebendazole 500 mg.

    Period 1
    Period 1 title
    Open Label (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Mebendazole 500 mg
    Arm description
    		 Participants received a single dose of Mebendazole 500-mg chewable tablet on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEBENDAZOLE
    Investigational medicinal product code
    SUB08660MIG
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single Dose of Mebendazole Chewable tablet 500 mg administered.

    Number of subjects in period 1
    		Mebendazole 500 mg
    Started
    396
    Completed
    390
    Not completed
    6
         Noncompliance with study drug
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mebendazole 500 mg
    Reporting group description
    		 Participants received a single dose of Mebendazole 500-mg chewable tablet on Day 1.

    Reporting group values
    		 Mebendazole 500 mg Total
    Number of subjects
    		 396 396
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 396 396
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65 to 84 years
    		 0 0
        85 years and over
    		 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 4.6 ( 1.94 ) -
    Title for Gender
    Units: subjects
        Female
    		 190 190
        Male
    		 206 206

    End points

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    End points reporting groups
    Reporting group title
    Mebendazole 500 mg
    Reporting group description
    		 Participants received a single dose of Mebendazole 500-mg chewable tablet on Day 1.

    Subject analysis set title
    Safety Analysis Set (SAS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set (SAS) includes Participants who received a single dose of mebendazole 500 mg and contributed any safety data after the start of study treatment.

    Primary: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [1]
    End point description
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 3 days after study drug administration
    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 inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 Mebendazole 500 mg
    Number of subjects analysed
    396 [2]
    Units: participants
    number (not applicable)
        Adverse Events
    44
        Serious AEs
    0
    Notes
    [2] - SAS
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Vital Signs

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    End point title
    		 Number of Participants with Abnormal Vital Signs
    End point description
    Vital signs included assessment of axillary temperature, pulse, respiratory rate, and BP on Day 1 and Day 3
    End point type
    Secondary
    End point timeframe
    Up to 3 Days after study drug administration
    End point values
    		 Mebendazole 500 mg
    Number of subjects analysed
    396 [3]
    Units: participants
        number (not applicable)
    289
    Notes
    [3] - SAS
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Physical Examinations at End-of-Study (EOS)

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    End point title
    		 Number of Participants with Abnormal Physical Examinations at End-of-Study (EOS)
    End point description
    Physical examination included evaluation of body organs (Skin, Eyes, Ears, Nose, Throat, Head, Neck, Thyroid, Heart, Lung, Chest (include Breasts), Abdomen, Genitalia, Anorectal, Lymph nodes, Musculoskeletal, Neurological, Other)
    End point type
    Secondary
    End point timeframe
    Up to 3 Days after study drug administration
    End point values
    		 Mebendazole 500 mg
    Number of subjects analysed
    396 [4]
    Units: participants
        number (not applicable)
    47
    Notes
    [4] - SAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 3 days after study drug administration
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Mebendazole 500 mg
    Reporting group description
    		 Participants received a single dose of Mebendazole 500-mg chewable tablet on Day 1.

    Serious adverse events
    		 Mebendazole 500 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 396 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Mebendazole 500 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 396 (11.11%)
    Investigations
    Respiratory Rate
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Cardiac Murmur
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Respiratory Rate Increased
         subjects affected / exposed
    2 / 396 (0.51%)
         occurrences all number
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    8 / 396 (2.02%)
         occurrences all number
    8
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    11 / 396 (2.78%)
         occurrences all number
    11
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Abdominal Pain
         subjects affected / exposed
    2 / 396 (0.51%)
         occurrences all number
    2
    Aphthous Stomatitis
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    10 / 396 (2.53%)
         occurrences all number
    10
    Nausea
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Oral Pain
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    5 / 396 (1.26%)
         occurrences all number
    5
    Asthma
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Rhonchi
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash Papular
         subjects affected / exposed
    3 / 396 (0.76%)
         occurrences all number
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 396 (0.51%)
         occurrences all number
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1
    Urinary Tract Infection
         subjects affected / exposed
    1 / 396 (0.25%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Oct 2009
    The overall reason for the amendment was to change in the protocol title to accurately reflect that medbendazole 500 mg is a new formulation of an existing drug (VERMOX®), but not a new drug, Replacement of oral temperature with axillary temperature, to clarify regarding stool samples, to address IRB concern on adverse events, Removal of reference to blood plasma and urine samples.
    21 Jan 2010
    The overall reason for the amendment was to modify wording of exclusion criteria and removal of reference to mebendazole as VERMOX.

    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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