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    Clinical Trial Results:
    Clinical trial to evaluate the efficacy and safety of oral Transidose in patients suffering from constipation.

    Summary
    EudraCT number
    		 2013-002900-15
    Trial protocol
    		 DE  
    Global end of trial date
    31 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2020
    First version publication date
    28 Jun 2020
    Other versions
    Summary report(s)
    		 Statistical Report Transidose final

    Trial information

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    Trial identification
    Sponsor protocol code
    Transidose-GE_01/2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Salsarulo Pharma
    Sponsor organisation address
    8 rue de l'Est, Boulogne-Billancourt, France, 92100
    Public contact
    Gilles Salsarulo, Salsarulo Pharma, 0033 618920891, gilles.salsarulo@salsapharma.com
    Scientific contact
    Gilles Salsarulo, Salsarulo Pharma, 0033 618920891, gilles.salsarulo@salsapharma.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
    07 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the efficacy and safety of Transidose p.o.
    Protection of trial subjects
    If diarrhea develops the dosage has to be reduced. If diarrhea persists, the treatment with Transidose has to be discontinued.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2014
    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
    Germany: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Candidates for the participation in this monocentric clinical trial are male and female patients as of 18 years of age, suffering from constipation with associated symptoms. Indication for inclusion in the study are rare bowel movements (stool frequency less than three times a week) and the fulfillment of the Rome III criteria. Moreover, a colon

    Pre-assignment
    Screening details
    		 The study is introduced by a wash-out period of one week. During this period, patients should not use laxatives. Afterwards the two-week active treatment period follows. The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening

    Period 1
    Period 1 title
    Period 1 - Wash-out
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Transidose
    Arm description
    		 The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening but not shortly before bedtime.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Transidose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral paste in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening but not shortly before bedtime.

    Number of subjects in period 1
    		Transidose
    Started
    10
    Completed
    10
    Period 2
    Period 2 title
    Period 2 - Active arm
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Transidose
    Arm description
    		 The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening but not shortly before bedtime.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Transidose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral paste in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening but not shortly before bedtime.

    Number of subjects in period 2
    		Transidose
    Started
    10
    Completed
    9
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1 - Wash-out
    Reporting group description
    		 -

    Reporting group values
    		 Period 1 - Wash-out Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 10 10
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.9 ( 11.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Transidose
    Reporting group description
    		 The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening but not shortly before bedtime.
    Reporting group title
    Transidose
    Reporting group description
    		 The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening but not shortly before bedtime.

    Primary: Difference of number of spontaneaous evacuation per week

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    End point title
    		 Difference of number of spontaneaous evacuation per week
    End point description
    End point type
    Primary
    End point timeframe
    After 2 weeks of treatment
    End point values
    		 Transidose Transidose
    Number of subjects analysed
    9
    9
    Units: Number of spontaneous evacuation per wee
        arithmetic mean (standard deviation)
    1.67 ( 0.50 )
    5.00 ( 1.94 )
    Statistical analysis title
    		 Wilcoxon test
    Comparison groups
    Transidose v Transidose
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Patient's judgement of efficacy

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    End point title
    		 Patient's judgement of efficacy
    End point description
    End point type
    Secondary
    End point timeframe
    After 2 weeks of treatment
    End point values
    		 Transidose
    Number of subjects analysed
    9
    Units: 1
        Very good
    2
        Good
    4
        Moderate
    2
        Poor
    1
    No statistical analyses for this end point

    Secondary: Bristol Stool Forms Scale

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    End point title
    		 Bristol Stool Forms Scale
    End point description
    End point type
    Secondary
    End point timeframe
    After 2 weeks of treatment
    End point values
    		 Transidose Transidose
    Number of subjects analysed
    9
    9
    Units: 1
        Typ 1
    7
    1
        Typ 2
    1
    2
        Typ 3
    0
    2
        Typ 4
    0
    1
        Typ 5
    0
    1
        Typ 6
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At treatment start, after 1 week of treatment and at final visit (after 2 weeks of treatment)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    AE reporting group
    Reporting group description
    		 -

    Serious adverse events
    		 AE reporting group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 AE reporting group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    7 / 9 (77.78%)
         occurrences all number
    41
    Discomfort
         subjects affected / exposed
    6 / 9 (66.67%)
         occurrences all number
    31
    Excessive straining
         subjects affected / exposed
    7 / 9 (77.78%)
         occurrences all number
    36
    Other
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    3
    Gastrointestinal disorders
    Bloating
         subjects affected / exposed
    8 / 9 (88.89%)
         occurrences all number
    42
    Bowel movements
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    4
    Unsatisfactory Defecations
         subjects affected / exposed
    8 / 9 (88.89%)
         occurrences all number
    38

    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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