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    Clinical Trial Results:
    Midazolam Measurement and Modelling using Matrix Samplers

    Summary
    EudraCT number
    		 2014-004958-34
    Trial protocol
    		 GB  
    Global end of trial date
    09 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Aug 2019
    First version publication date
    05 Aug 2019
    Other versions
    Summary report(s)
    		 4Ms Study Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    UNOLE0457
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Of Leicester
    Sponsor organisation address
    University Road , Leicester , United Kingdom, LE1 7RH
    Public contact
    Hitesh Pandya, University of Leicester, hp28@le.ac.uk
    Scientific contact
    Hitesh Pandya, University of Leicester, hp28@le.ac.uk
    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
    09 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Main objective of the trial: To determine whether critically ill children metabolise midazolam differently to otherwise healthy children undergoing routine surgery. Secondary objective of the trial: To determine whether blood midazolam level measurements made from micro-volume samples of dried blood are equivalent to blood midazolam measurements made using wet blood samples.
    Protection of trial subjects
    NA
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    02 Feb 2015
    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 Kingdom: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    47
    Children (2-11 years)
    43
    Adolescents (12-17 years)
    10
    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
    		 NA

    Pre-assignment
    Screening details
    		 NA

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall Trial
    Arm description
    		 Not applicable
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIDAZOLAM
    Investigational medicinal product code
    SUB08950MIG
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous bolus use , Intravenous drip use
    Dosage and administration details
    Dosage administered by the direct care team according to the local hospital policy

    Number of subjects in period 1
    		Overall Trial
    Started
    100
    Completed
    100

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 Not applicable

    Subject analysis set title
    PICU Cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    PICU Cohort

    Subject analysis set title
    Surgical cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Surgical Cohort

    Primary: Midazolam Concentration

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    End point title
    		 Midazolam Concentration [1]
    End point description
    Primary end point(s): To determine midazolam pharmacokinetic (PK) parameters (clearance, volume of distribution and half-life) in critically ill children and in otherwise healthy children undergoing surgery. Secondary end point(s): To determine whether measurement of midazolam levels using microvolume samples of dried blood is equivalent to midazolam measurements made using wet blood samples.
    End point type
    Primary
    End point timeframe
    Duration of Trial
    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: Only descriptive analysis was undertaken.
    End point values
    		 Overall Trial PICU Cohort Surgical cohort
    Number of subjects analysed
    100 [2]
    64 [3]
    36 [4]
    Units: ng/ml
        arithmetic mean (full range (min-max))
    188 (5 to 1987)
    332 (5 to 1987)
    28 (5 to 356)
    Notes
    [2] - All subjects
    [3] - PICU Cohort
    [4] - Surgical Cohort
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All Safety Reporting was according to Sponsor (University of Leicester) processes, and as per the study protocol.
    Adverse event reporting additional description
    Common adverse events and adverse effects occurring during the trial was expected, as a consequence of the underlying condition, or surgical procedures and therefore were not be recorded in the CRF or collected as a part of the study procedures.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Common adverse events and adverse effects occurring during the trial were expected, as a consequence of the underlying condition, or surgical procedures and therefore were not be recorded in the CRF or collected as a part of the study procedures. Any adverse events or adverse reactions that were experienced during the study period were dealt within a clinically relevant manner by the direct care team and details were recorded in the clinical notes where applicable.

    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.
    NA
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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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