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    Clinical Trial Results:
    Unilateral, open and randomized phase IV study of 2 groups to assess the degree of comfort with simple Emuliquen® in patients undergoing proctological surgery

    Summary
    EudraCT number
    		 2017-002811-33
    Trial protocol
    		 ES  
    Global end of trial date
    20 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2022
    First version publication date
    23 Jul 2022
    Other versions
    Summary report(s)
    		 RESUMEN DE RESULTADOS_LAINCO1107

    Trial information

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    Trial identification
    Sponsor protocol code
    LAINCO1107
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LAINCO S.A.
    Sponsor organisation address
    Avda. Bizet 8-12 , Rubí, Barcelona, Spain,
    Public contact
    Anna Royo, Dynamic, 0034 933511615, a.royo@evidenze.com
    Scientific contact
    Anna Royo, Dynamic, 0034 933511615, a.royo@evidenze.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
    20 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the degree of comfort that patients experience after undergoing proctological surgery
    Protection of trial subjects
    Study performed folowing good clinical practices and royal decree 190/2015
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Dec 2017
    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
    Spain: 110
    Worldwide total number of subjects
    110
    EEA total number of subjects
    110
    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)
    93
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening of 21 days where inclusion criteria are confirmed. It coincides with the pre-operative period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Emuliquen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral emulsion
    Routes of administration
    Oral use
    Dosage and administration details
    500mg/ml every day at least 4 weeks and a maximum of 5 weeks.

    Arm title
    		 Group B
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lactulosa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    10gr every day for at least 4 weeks and a maximum of 5 weeks.

    Number of subjects in period 1
    		Group A Group B
    Started
    56
    54
    Completed
    49
    41
    Not completed
    7
    13
         Consent withdrawn by subject
    4
    5
         Adverse event, non-fatal
    -
    2
         Pregnancy
    -
    1
         Lost to follow-up
    3
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 -

    Reporting group title
    Group B
    Reporting group description
    		 -

    Reporting group values
    		 Group A Group B Total
    Number of subjects
    		 56 54 110
    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)
    		 47.3 ( 12.6 ) 51.6 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 19 41
        Male
    		 34 35 69

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 -

    Reporting group title
    Group B
    Reporting group description
    		 -

    Primary: intestinal colic episodes

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    End point title
    		 intestinal colic episodes
    End point description
    The results are presented as number of patients with at least one intestinal colic during all the study.
    End point type
    Primary
    End point timeframe
    All the study, since the first dose until the end of the treatment.
    End point values
    		 Group A Group B
    Number of subjects analysed
    37 [1]
    26 [2]
    Units: Number of patients
        YES
    23
    14
        NO
    14
    12
    Notes
    [1] - Per protocol population
    [2] - Per protocol population
    Statistical analysis title
    		 Chi squared
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.509 [3]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [3] - Statistically non-significant

    Primary: flatulence episodes

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    End point title
    		 flatulence episodes
    End point description
    The results are presented as number of patients with at least one intestinal colic
    End point type
    Primary
    End point timeframe
    All the study, since the first dose until the end of the treatment.
    End point values
    		 Group A Group B
    Number of subjects analysed
    37
    27
    Units: Number of patients
        YES
    36
    27
        NO
    1
    0
    Statistical analysis title
    		 Fisher
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.999 [4]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [4] - statistically non-significant

    Secondary: degree of effort during defecation

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    End point title
    		 degree of effort during defecation
    End point description
    The results are presented as number of patients with at least one intestinal colic during all the study.
    End point type
    Secondary
    End point timeframe
    All the study, since the first dose until the end of the treatment.
    End point values
    		 Group A Group B
    Number of subjects analysed
    37 [5]
    27 [6]
    Units: Patients
        YES
    33
    25
        NO
    4
    2
    Notes
    [5] - Per protocol population
    [6] - Per protocol population
    Statistical analysis title
    		 Fisher
    Comparison groups
    Group B v Group A
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.999
    Method
    		 Fisher exact
    Confidence interval

    Secondary: degree of pain during defecation

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    End point title
    		 degree of pain during defecation
    End point description
    End point type
    Secondary
    End point timeframe
    All the study, since the first dose until the end of the treatment.
    End point values
    		 Group A Group B
    Number of subjects analysed
    37 [7]
    27 [8]
    Units: EVA scale
        arithmetic mean (standard deviation)
    3.4 ( 2.4 )
    3.1 ( 2.0 )
    Notes
    [7] - per protocol population
    [8] - per protocol population
    No statistical analyses for this end point

    Secondary: episodes of diarrhoea

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    End point title
    		 episodes of diarrhoea
    End point description
    The results are presented as number of patients with at least one diarrhea episode during all the study.
    End point type
    Secondary
    End point timeframe
    All the study, since the first dose until the end of the treatment.
    End point values
    		 Group A Group B
    Number of subjects analysed
    36
    27
    Units: Patients
        YES
    23
    14
        NO
    13
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Since signature of informed consent until the last visit of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Safety population (group A)
    Reporting group description
    		 -

    Reporting group title
    Safety population (group B)
    Reporting group description
    		 -

    Serious adverse events
    		 Safety population (group A) Safety population (group B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 54 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety population (group A) Safety population (group B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 54 (5.56%)
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Pain after defecation
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1

    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.
    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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