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    Clinical Trial Results:
    A RANDOMISED, SINGLE-BLIND, ACTIVE CONTROLLED, MULTI-CENTRE TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, ACCEPTABILITY AND PALATABILITY OF PMF104 COMPARED TO A CONVENTIONAL PEG-ELECTROLYTE SOLUTION IN CHILDREN AGED FROM 2 TO LESS THAN 6, FROM 6 TO LESS THAN 12 AND ADOLESCENTS FROM 12 TO LESS THAN 18 YEARS OF AGE REQUIRING A DIAGNOSTIC PROCEDURE CONCERNING THE COLON

    Summary
    EudraCT number
    		 2015-002969-27
    Trial protocol
    		 IT   BE   FR  
    Global end of trial date
    22 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jul 2022
    First version publication date
    09 Jul 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PMF104 PD1-2-3/2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 CRO-15-125: CRO code
    Sponsors
    Sponsor organisation name
    Alfasigma S.p.A.
    Sponsor organisation address
    Via Ragazzi del '99, 5, Bologna, Italy,
    Public contact
    Raffaella Tacchi, Alfasigma S.p.A., raffaella.tacchi@alfasigma.com
    Scientific contact
    Raffaella Tacchi, Alfasigma S.p.A., raffaella.tacchi@alfasigma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001356-PIP02-12
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jan 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to Klean-prep® in children aged from 2 to less than 18 years old requiring a diagnostic procedure of the colon.
    Protection of trial subjects
    Before initiating the trial, the Sponsor and the investigators/institutions obtained written and dated approval/favourable opinion from the IRB/IEC for the trial protocol, written informed consent and assent forms and any other written/oral information provided to the paediatric subjects and their parents or legal representatives. The Sponsor provided the IRB/IEC with a current copy of the Investigator's Brochure and any updated copy prepared during the trial, when requested. The Sponsor and the investigators/Institutions obtained approval/favourable opinion from the IRB/IEC for change(s) to any aspect of the trial, such as modification(s) of the protocol, written informed consent form, written information provided to subjects. The Sponsor had to promptly report any new information that could affect the safety of the paediatric subjects or the conduct of the trial to both the IRB/IEC and the Regulatory Authorities, if applicable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Apr 2016
    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
    Belgium: 14
    Country: Number of subjects enrolled
    France: 51
    Country: Number of subjects enrolled
    Italy: 291
    Worldwide total number of subjects
    356
    EEA total number of subjects
    356
    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)
    201
    Adolescents (12-17 years)
    155
    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
    		 The study was performed in 8 clinical centres in Europe: 5 centres in Italy, 1 centre in Belgium and 2 centres in France.

    Pre-assignment
    Screening details
    		 Overall 357 subjects were screened

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    During the study a single-blind design with respect to the investigational products was achieved by providing the randomisation list only to the unblinded study staff personnel who handled study drug management, preparation, dispensation and collection but who was not involved in colonoscopy performing. Only the endoscopist performing the colonoscopy was blinded regarding the treatment assigned.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PMF104
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    PMF104
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    PMF104 solution was administered the day before the diagnostic procedure concerning the colon, starting in the mid-late afternoon (4-6 p.m.), as a single dose by oral route. A nasogastric tube was inserted in children unable to drink the required amount of solution (in-patients only).

    Arm title
    		 Klean-Prep®
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Klean-Prep®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Klean-Prep® solution was administered the day before the diagnostic procedure concerning the colon, starting in the mid-late afternoon (4-6 p.m.), as a single dose by oral route. A nasogastric tube was placed in children unable to drink the required amount of solution (in-patients only).

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: During the study a single-blind design with respect to the investigational products was achieved by providing the randomisation list only to the unblinded study staff personnel who handled study drug management, preparation, dispensation and collection but who was not involved in colonoscopy performing. Only the endoscopist performing the colonoscopy was blinded regarding the treatment assigned.
    Number of subjects in period 1
    		PMF104 Klean-Prep®
    Started
    179
    177
    Completed
    169
    176
    Not completed
    10
    1
         Physician decision
    2
    -
         Adverse event, non-fatal
    4
    -
         Technical problems
    1
    -
         Lost to follow-up
    2
    1
         Withdrawal by parent/guardian
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PMF104
    Reporting group description
    		 -

    Reporting group title
    Klean-Prep®
    Reporting group description
    		 -

    Reporting group values
    		 PMF104 Klean-Prep® Total
    Number of subjects
    		 179 177 356
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 101 100 201
        Adolescents (12-17 years)
    		 78 77 155
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.6 ( 3.9 ) 10.5 ( 3.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 82 76 158
        Male
    		 97 101 198

    End points

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    End points reporting groups
    Reporting group title
    PMF104
    Reporting group description
    		 -

    Reporting group title
    Klean-Prep®
    Reporting group description
    		 -

    Subject analysis set title
    Per Protocol Set (PP) PMF104 2-<6 years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set includes the subjects (age stratum 2-<6 years) of the FAS (i.e. all randomised patients who received at least a fraction of the dose of the investigational product and have at least the BBPS score of any of the 3 broad regions of the colon [right colon, transverse colon or left colon]) who have a Good or Optimal compliance to PMF104 (regardless of the intake of a rescue dose) and have the BBPS scores of all the 3 broad regions of the colon (right colon, transverse colon and left colon), without any major protocol deviation that has an impact on the efficacy outcomes.

    Subject analysis set title
    Per Protocol Set (PP) Klean-Prep® 2-<6 years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set includes the subjects (age stratum 2-<6 years) of the FAS (i.e. all randomised patients who received at least a fraction of the dose of the investigational product and have at least the BBPS score of any of the 3 broad regions of the colon [right colon, transverse colon or left colon]) who have a Good or Optimal compliance to Klean-Prep® (regardless of the intake of a rescue dose) and have the BBPS scores of all the 3 broad regions of the colon (right colon, transverse colon and left colon), without any major protocol deviation that has an impact on the efficacy outcomes.

    Subject analysis set title
    Safety Set PMF104
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set includes all subjects who received at least a fraction of the dose of PMF104. These subjects were included in the safety analysis.

    Subject analysis set title
    Safety Set Klean-Prep®
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set includes all subjects who received at least a fraction of the dose of Klean-Prep®. These subjects were included in the safety analysis.

    Subject analysis set title
    Per Protocol Set (PP) PMF104 6-<12 years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set includes the subjects (age stratum 6-<12 years) of the FAS (i.e. all randomised patients who received at least a fraction of the dose of the investigational product and have at least the BBPS score of any of the 3 broad regions of the colon [right colon, transverse colon or left colon]) who have a Good or Optimal compliance to PMF104 (regardless of the intake of a rescue dose) and have the BBPS scores of all the 3 broad regions of the colon (right colon, transverse colon and left colon), without any major protocol deviation that has an impact on the efficacy outcomes.

    Subject analysis set title
    Per Protocol Set (PP) Klean-Prep® 6-<12 years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set includes the subjects (age stratum 6-<12 years) of the FASc(i.e. all randomised patients who received at least a fraction of the dose of the investigational product and have at least the BBPS score of any of the 3 broad regions of the colon [right colon, transverse colon or left colon]) who have a Good or Optimal compliance to Klean-Prep® (regardless of the intake of a rescue dose) and have the BBPS scores of all the 3 broad regions of the colon (right colon, transverse colon and left colon), without any major protocol deviation that has an impact on the efficacy outcomes.

    Subject analysis set title
    Per Protocol Set (PP) PMF104 12-<18 years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set includes the subjects (age stratum 12-<18 years) of the FAS (i.e. all randomised patients who received at least a fraction of the dose of the investigational product and have at least the BBPS score of any of the 3 broad regions of the colon [right colon, transverse colon or left colon]) who have a Good or Optimal compliance to PMF104 (regardless of the intake of a rescue dose) and have the BBPS scores of all the 3 broad regions of the colon (right colon, transverse colon and left colon), without any major protocol deviation that has an impact on the efficacy outcomes.

    Subject analysis set title
    Per Protocol Set (PP) Klean-Prep® 12-<18 years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set includes the subjects (age stratum 12-<18 years) of the FAS (i.e. all randomised patients who received at least a fraction of the dose of the investigational product and have at least the BBPS score of any of the 3 broad regions of the colon [right colon, transverse colon or left colon]) who have a Good or Optimal compliance to Klean-Prep® (regardless of the intake of a rescue dose) and have the BBPS scores of all the 3 broad regions of the colon (right colon, transverse colon and left colon), without any major protocol deviation that has an impact on the efficacy outcomes.

    Primary: Mean (total) BBPS score - Age stratum 2-<6 years

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    End point title
    		 Mean (total) BBPS score - Age stratum 2-<6 years
    End point description
    The primary endpoint is the difference between Clensia (PMF104) and Klean-Prep in terms of colon cleansing at day 2 as assessed by the Boston Bowel Preparation Scale (BBPS) score, with the objective of demonstrating non inferiority of PMF104 compared to the reference product (Klean-Prep). Age stratum 2-<6 years.
    End point type
    Primary
    End point timeframe
    Day 1: drug administration. Day 2: evaluation of primary endpoint.
    End point values
    		 Per Protocol Set (PP) PMF104 2-<6 years Per Protocol Set (PP) Klean-Prep® 2-<6 years
    Number of subjects analysed
    16
    16
    Units: BBPS score
        arithmetic mean (standard deviation)
    5.9 ( 2.2 )
    6.6 ( 2.3 )
    Statistical analysis title
    		 Efficacy statistical analysis
    Comparison groups
    Per Protocol Set (PP) PMF104 2-<6 years v Per Protocol Set (PP) Klean-Prep® 2-<6 years
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -0.7357
    Confidence interval
         level
    		 90%
         sides
    1-sided
         lower limit
    		 -1.6962
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Primary: Mean (total) BBPS score - Age stratum 6-<12 years

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    End point title
    		 Mean (total) BBPS score - Age stratum 6-<12 years
    End point description
    The primary endpoint is the difference between Clensia (PMF104) and Klean-Prep in terms of colon cleansing at day 2 as assessed by the Boston Bowel Preparation Scale (BBPS) score, with the objective of demonstrating non inferiority of PMF104 compared to the reference product (Klean-Prep). Age stratum 6 - <12 years
    End point type
    Primary
    End point timeframe
    Day 1: drug administration. Day 2: evaluation of primary endpoint.
    End point values
    		 Per Protocol Set (PP) PMF104 6-<12 years Per Protocol Set (PP) Klean-Prep® 6-<12 years
    Number of subjects analysed
    50
    59
    Units: BBPS score
        arithmetic mean (standard deviation)
    6.6 ( 1.9 )
    6.5 ( 1.8 )
    Statistical analysis title
    		 Efficacy statistical analysis
    Comparison groups
    Per Protocol Set (PP) PMF104 6-<12 years v Per Protocol Set (PP) Klean-Prep® 6-<12 years
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    0.1309
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -0.5097
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Primary: Mean (total) BBPS score - Age stratum 12-<18 years

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    End point title
    		 Mean (total) BBPS score - Age stratum 12-<18 years
    End point description
    The primary endpoint is the difference between Clensia (PMF104) and Klean-Prep in terms of colon cleansing at day 2 as assessed by the Boston Bowel Preparation Scale (BBPS) score, with the objective of demonstrating non inferiority of PMF104 compared to the reference product (Klean-Prep). Age stratum 12 - <18 years.
    End point type
    Primary
    End point timeframe
    Day 1: drug administration. Day 2: evaluation of primary endpoint.
    End point values
    		 Per Protocol Set (PP) PMF104 12-<18 years Per Protocol Set (PP) Klean-Prep® 12-<18 years
    Number of subjects analysed
    56
    61
    Units: BBPS score
        arithmetic mean (standard deviation)
    6.1 ( 2.1 )
    6.0 ( 2.0 )
    Statistical analysis title
    		 Efficacy statistical analysis
    Comparison groups
    Per Protocol Set (PP) PMF104 12-<18 years v Per Protocol Set (PP) Klean-Prep® 12-<18 years
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    0.1781
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -0.5035
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Safety Set PMF104 2-<6 years
    Reporting group description
    		 -

    Reporting group title
    Safety Set PMF104 6-<12 years
    Reporting group description
    		 -

    Reporting group title
    Safety Set PMF104 12-<18 years
    Reporting group description
    		 -

    Reporting group title
    Safety Set Klean-Prep 2-<6 years
    Reporting group description
    		 -

    Reporting group title
    Safety Set Klean-Prep 6-<12 years
    Reporting group description
    		 -

    Reporting group title
    Safety Set Klean-Prep 12-<18 years
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Set PMF104 2-<6 years Safety Set PMF104 6-<12 years Safety Set PMF104 12-<18 years Safety Set Klean-Prep 2-<6 years Safety Set Klean-Prep 6-<12 years Safety Set Klean-Prep 12-<18 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    1 / 26 (3.85%)
    0 / 74 (0.00%)
    4 / 77 (5.19%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Haemorrhagic arteriovenous malformation
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    1 / 26 (3.85%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal polyp haemorrhage
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    3 / 77 (3.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Safety Set PMF104 2-<6 years Safety Set PMF104 6-<12 years Safety Set PMF104 12-<18 years Safety Set Klean-Prep 2-<6 years Safety Set Klean-Prep 6-<12 years Safety Set Klean-Prep 12-<18 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 22 (59.09%)
    48 / 77 (62.34%)
    59 / 75 (78.67%)
    15 / 26 (57.69%)
    50 / 74 (67.57%)
    60 / 77 (77.92%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    2 / 74 (2.70%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 22 (9.09%)
    19 / 77 (24.68%)
    14 / 75 (18.67%)
    3 / 26 (11.54%)
    16 / 74 (21.62%)
    25 / 77 (32.47%)
         occurrences all number
    2
    20
    14
    3
    16
    27
    Asthenia
         subjects affected / exposed
    0 / 22 (0.00%)
    3 / 77 (3.90%)
    8 / 75 (10.67%)
    0 / 26 (0.00%)
    4 / 74 (5.41%)
    9 / 77 (11.69%)
         occurrences all number
    0
    3
    8
    0
    4
    9
    pyrexia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    2 / 75 (2.67%)
    0 / 26 (0.00%)
    2 / 74 (2.70%)
    3 / 77 (3.90%)
         occurrences all number
    0
    0
    2
    0
    2
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 22 (18.18%)
    31 / 77 (40.26%)
    35 / 75 (46.67%)
    5 / 26 (19.23%)
    26 / 74 (35.14%)
    48 / 77 (62.34%)
         occurrences all number
    4
    34
    38
    6
    27
    53
    Abdominal pain
         subjects affected / exposed
    6 / 22 (27.27%)
    19 / 77 (24.68%)
    35 / 75 (46.67%)
    6 / 26 (23.08%)
    22 / 74 (29.73%)
    23 / 77 (29.87%)
         occurrences all number
    6
    21
    37
    6
    23
    29
    Abdominal distension
         subjects affected / exposed
    3 / 22 (13.64%)
    12 / 77 (15.58%)
    27 / 75 (36.00%)
    1 / 26 (3.85%)
    19 / 74 (25.68%)
    31 / 77 (40.26%)
         occurrences all number
    3
    12
    28
    1
    19
    32
    Vomiting
         subjects affected / exposed
    5 / 22 (22.73%)
    20 / 77 (25.97%)
    16 / 75 (21.33%)
    7 / 26 (26.92%)
    15 / 74 (20.27%)
    21 / 77 (27.27%)
         occurrences all number
    5
    21
    17
    9
    17
    28
    Anorectal discomfort
         subjects affected / exposed
    2 / 22 (9.09%)
    5 / 77 (6.49%)
    10 / 75 (13.33%)
    1 / 26 (3.85%)
    8 / 74 (10.81%)
    17 / 77 (22.08%)
         occurrences all number
    2
    5
    10
    1
    8
    19
    Diarrhoea
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    3 / 75 (4.00%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    4 / 77 (5.19%)
         occurrences all number
    0
    0
    3
    0
    0
    4
    Gastritis
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 77 (2.60%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    2 / 74 (2.70%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    2 / 75 (2.67%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    Haematochezia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    1 / 26 (3.85%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Enterobiasis
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 77 (2.60%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    1 / 74 (1.35%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    0 / 74 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    0
    0
    0
    0
    0
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Nov 2015
    An exclusion criterion was modified and an additional exclusion criterion was added.
    23 Nov 2016
    • The number of participating clinical sites was increased in order to increase the low enrolment rate observed in the first months of the study. • The analysis model was integrated, with an additional analysis to be performed beside the originally planned analysis. • The inclusion criterion concerning fertile subjects was integrated. • Modification of a pre-screening clinical laboratory test schedule.
    15 Sep 2017
    This amendment was released to notify the change in the study Sponsor and legal representative. On 01 August 2017 Alfa Wassermann S.p.A. was merged with and incorporated in Alfasigma S.p.A. The latter became the study Sponsor and legal representative.
    02 Jul 2018
    • Reduction in the number of subjects to be included in the first (2-<6 years) age stratum as compared to the original protocol. • Change in the Statistical Plan with respect to the study population in the age stratum 2-<6 years. • Extension of enrolment period up to July 2020. • Reference to General Data Protection Regulation and data breach management was enclosed.

    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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