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    Clinical Trial Results:
    Optimising the use of Entonox during screening colonoscopy: an open randomised controlled trial

    Summary
    EudraCT number
    		 2012-003342-33
    Trial protocol
    		 GB  
    Global end of trial date
    08 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Nov 2019
    First version publication date
    07 Nov 2019
    Other versions
    Summary report(s)
    		 End of Trial Report

    Trial information

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    Trial identification
    Sponsor protocol code
    STH16359
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01865721
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS Foundation Trust
    Sponsor organisation address
    Trust Headquarters, 8 Beech Hill Road, Sheffield, United Kingdom, S10 2SB
    Public contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    Scientific contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.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
    09 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does continuous use of Entonox® reduce pain severity during colonoscopy?
    Protection of trial subjects
    Patient consent was obtained as per REC approved process. The study took place within standard care - all patients were having colonoscopies for clinically indicated reasons
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Oct 2012
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    35
    From 65 to 84 years
    65
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from those planned to undergo colonoscopy for clinically indicated reasons at Sheffield Teaching Hospitals NHS Foundation Trust.

    Pre-assignment
    Screening details
    		 Patients referred for a screening colonoscopy, following a positive faecal occult blood (FOB) were invited to participate. Colonoscopy examinations were performed at the Northern General Hospital, Sheffield, between January 2013 and April 2014. Patients wishing to use Entonox were considered for inclusion.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Continous Use
    Arm description
    		 Entonox administered continuously throughout colonoscopy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Entonox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    50% Oxygen, 50% Nitrous Oxide, administered by inhalation continuously

    Arm title
    		 As required use
    Arm description
    		 Entonox administered as required throughout colonoscopy
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Entonox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    50% oxygen, 50% nitrous oxide, inhaled as required

    Number of subjects in period 1
    		Continous Use As required use
    Started
    46
    54
    Completed
    46
    54

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Continous Use
    Reporting group description
    		 Entonox administered continuously throughout colonoscopy

    Reporting group title
    As required use
    Reporting group description
    		 Entonox administered as required throughout colonoscopy

    Reporting group values
    		 Continous Use As required use Total
    Number of subjects
    		 46 54 100
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.7 ( 4.1 ) 66.5 ( 4.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 11 25
        Male
    		 32 43 75

    End points

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    End points reporting groups
    Reporting group title
    Continous Use
    Reporting group description
    		 Entonox administered continuously throughout colonoscopy

    Reporting group title
    As required use
    Reporting group description
    		 Entonox administered as required throughout colonoscopy

    Primary: Overall pain rating prior to discharge

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    End point title
    		 Overall pain rating prior to discharge
    End point description
    End point type
    Primary
    End point timeframe
    Overall pain rating prior to discharge
    End point values
    		 Continous Use As required use
    Number of subjects analysed
    46
    54
    Units: score out of 10
        arithmetic mean (standard deviation)
    2.4 ( 2.2 )
    3.2 ( 2.1 )
    Statistical analysis title
    		 primary endpoint
    Comparison groups
    Continous Use v As required use
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During colonoscopy
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Continous Use
    Reporting group description
    		 Entonox administered continuously throughout colonoscopy

    Reporting group title
    As required use
    Reporting group description
    		 Entonox administered as required throughout colonoscopy

    Serious adverse events
    		 Continous Use As required use
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 39 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Continous Use As required use
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 46 (97.83%)
    34 / 39 (87.18%)
    Nervous system disorders
    Light headedness
         subjects affected / exposed
    22 / 46 (47.83%)
    8 / 39 (20.51%)
         occurrences all number
    22
    8
    Paraesthesia
         subjects affected / exposed
    3 / 46 (6.52%)
    1 / 39 (2.56%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 46 (6.52%)
    3 / 39 (7.69%)
         occurrences all number
    3
    3
    Dry Mouth
         subjects affected / exposed
    39 / 46 (84.78%)
    34 / 39 (87.18%)
         occurrences all number
    39
    34
    Psychiatric disorders
    Dysphoria
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 39 (0.00%)
         occurrences all number
    3
    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.
    The study ceased recruitment following the interim futility analysis of 100 patients pain ratings prior to discharge, which revealed that there were no clinically significant differences between the two groups (<1 point on a 10 point scale).

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25629571
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