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    Clinical Trial Results:
    Randomized, double blind, placebo-controlled trial of Creon in patients with low faecal pancreatic elastase

    Summary
    EudraCT number
    		 2011-006019-73
    Trial protocol
    		 GB  
    Global end of trial date
    22 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2019
    First version publication date
    12 May 2019
    Other versions
    Summary report(s)
    		 final report

    Trial information

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    Trial identification
    Sponsor protocol code
    STH16190
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01865695
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS Foundation Trust
    Sponsor organisation address
    Of Trust Headquarters, 8 Beech Hill Road, Sheffield, United Kingdom, S10 2SB
    Public contact
    Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, ResearchAdministration@sth.nhs.uk
    Scientific contact
    Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, ResearchAdministration@sth.nhs.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
    22 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    What is the effect of Creon in patients with low faecal pancreatic elastase? 1) Creon being the IMP we propose to evaluate in this study. 2) Low faecal pancreatic elastase being a marker of pancreatic insufficiency
    Protection of trial subjects
    No measures in place as events deemed this unnecessary
    Background therapy
    		 Creon is a pancreatic enzyme supplement used in patients with low faecal pancreatic elastase. The study aimed to assess the impact of creon on quality of life
    Evidence for comparator
    		 no comparators were used
    Actual start date of recruitment
    01 Nov 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: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitment period 05/12/2012 - 30/11/2014 2 recruited initially but subsequently excluded

    Pre-assignment
    Screening details
    		 not applicable

    Period 1
    Period 1 title
    overall trial period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 creon
    Arm description
    		 Active treatment will be 2 capsules of Creon 25,000 units three times per day and the placebo will be 2 capsules three times per day; for 6 weeks treatment overall
    Arm type
    		 Experimental

    Investigational medicinal product name
    creon
    Investigational medicinal product code
    00032-1224
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 capsules of Creon 25,000 units three times per day

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    n/a
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 capsules three times per day

    Number of subjects in period 1
    		creon
    Started
    2
    Completed
    0
    Not completed
    2
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    creon
    Reporting group description
    		 Active treatment will be 2 capsules of Creon 25,000 units three times per day and the placebo will be 2 capsules three times per day; for 6 weeks treatment overall

    Reporting group values
    		 creon Total
    Number of subjects
    		 2 2
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 2
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 55 (18 to 64) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    creon
    Reporting group description
    		 Active treatment will be 2 capsules of Creon 25,000 units three times per day and the placebo will be 2 capsules three times per day; for 6 weeks treatment overall

    Primary: stool frequency

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    End point title
    		 stool frequency [1]
    End point description
    Effect of Creon on stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment
    End point type
    Primary
    End point timeframe
    6 weeks
    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 participants completed this study, no data collected, therefore no analysis could take place.
    End point values
    		 creon
    Number of subjects analysed
    0 [2]
    Units: 6 weeks
    Notes
    [2] - no data as all participants withdrawn from study
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    6 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    5.0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: no adverse events recorded as no participants proceeded in study

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Oct 2013
    Patient Symptom Diary added to study documentation to replace Symptom Questionnaire that was originally approved by REC. The symptom diary is a validated tool which collects data on the primary and secondary endpoints more completely than the previous symptom questionnaire. The Protocol was amended to fully and consistently document when the patient diary is to be completed at baseline and follow up. This exclusion criterion was added on advice of NHS REC. This change was previously approved by REC but MHRA was not previously notified as it was considered that this change was non-substantial for submission to MHRA as it did not significantly affect the scientific integrity or safety of the trial. The exclusion criteria added related to Patients who are unable to speak or understand English.

    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.
    2 participants were recruited however they were then excluded as they were not followed up in line with the protocol. The study team then chose to cancel the study due to difficulties with recruitment. Therefore no data has been added to this report.
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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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