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    Clinical Trial Results:
    A randomized, assessor-blinded, multicenter, international study investigating efficacy, patient's acceptance, safety and tolerability of Sodium Phosphate tablets compared to split dose Polyethylene Glycol for colon cleansing prior to colonoscopy.

    Summary
    EudraCT number
    		 2012-005115-13
    Trial protocol
    		 ES  
    Global end of trial date
    06 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2016
    First version publication date
    31 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ICOL121
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01840553
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MAYOLY SPINDLER
    Sponsor organisation address
    6 avenue de l'europe, chatou, France, 78400
    Public contact
    Valérie O'Mahony, Mayoly Spindler, 33 0134804102, valerie.omahony@mayoly.com
    Scientific contact
    Valérie O'Mahony, Mayoly Spindler, 33 0134804102, valerie.omahony@mayoly.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
    02 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the efficacy of sodium phosphate tablets versus split dose of 4 liters of PEG for bowel cleansing prior to colonoscopy.
    Protection of trial subjects
    Subjects had a follow up visit 7 to 10 days after last study medication intake for safety follow up
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Apr 2013
    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: 172
    Country: Number of subjects enrolled
    France: 216
    Country: Number of subjects enrolled
    Germany: 73
    Worldwide total number of subjects
    461
    EEA total number of subjects
    461
    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)
    390
    From 65 to 84 years
    71
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients undergoing total colonoscopy for screening or surveillance colonoscopy from April 2013 to March 2014 were selected for inclusion in the study in 3 European countries (France, Germany and Spain).

    Pre-assignment
    Screening details
    		 Patients undergoing total colonoscopy were selected, aged from 18 to 75 years, eligible for both treatments, had a normal renal function and no contraindication for sodium phosphate . Overall, inclusion and exclusion criteria were defined according to the SMPC.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    Colonoscopies were video-recorded. Two independent experienced gastroenterologists, blinded for treatment reviewed and scored the quality of the preparation for assessment. For any discrepancies, a third blinded expert determined the BBPS score.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sodium phosphate tablets
    Arm description
    		 Sodium phosphate tablets
    Arm type
    		 Experimental

    Investigational medicinal product name
    sodium phosphate tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 32 tablets of sodium phosphate bowel preparation (NaP, Colokit©) in total. Each tablet contains monobasic monohydrate sodium phosphate (1102 mg) and dibasic anhydrous sodium phosphate (398 mg). The evening before the examination, patients took a first sequence : 4 NaP tablets with 250mL of water (or another clear liquid) every 15 minutes, repeated a further 4 times for a total of 20 tablets. On the day of the examination, patients took the second sequence :4 tablets of NaP every 15 minutes, in addition to 250mL of water (or another clear liquid), repeated another two times under the same conditions, i.e.12 tablets in total.

    Arm title
    		 Polyethylene glycol
    Arm description
    		 Polyethylene glycol
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Polyethylene glycol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 4 liters of PEG (Klean-Prep©) in total before colonoscopy. Preparation was standardized as follows: The day before the examination, two sachets were taken during the evening. The remaining two sachets were taken in the morning of the examination day, starting 4-8 hours prior to the colonoscopy. Each sachet was dissolved in one liter of water and taken at a rate of 250mL every 10 to 15 minutes.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: patients and investigators were not blinded but the primary efficacy criteria was assess by blinded assessors (videos of the colonoscopies)
    Number of subjects in period 1 [2]
    		Sodium phosphate tablets Polyethylene glycol
    Started
    226
    226
    Completed
    226
    218
    Not completed
    0
    8
         Consent withdrawn by subject
    -
    1
         colonoscopy not performed
    -
    4
         poor compliance
    -
    2
         Lost to follow-up
    -
    1
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 461 patients were randomised but only 452 received the study treatments. 9 didn't receive treatment: 4 consent withdrawal, 2 lost of follow up, 2 adverse event and 1 for other reason

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 452 452
    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)
    		 386 386
        From 65-84 years
    		 66 66
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 225 225
        Male
    		 227 227
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) includes all subjects who received any study medication for whom the BBPS score was obtained (primary efficacy endpoint), disregarding any protocol deviation.

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    429
    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)
    367
        From 65-84 years
    62
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    214
        Male
    215

    End points

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    End points reporting groups
    Reporting group title
    Sodium phosphate tablets
    Reporting group description
    		 Sodium phosphate tablets

    Reporting group title
    Polyethylene glycol
    Reporting group description
    		 Polyethylene glycol

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) includes all subjects who received any study medication for whom the BBPS score was obtained (primary efficacy endpoint), disregarding any protocol deviation.

    Primary: overall quality of bowel cleansing

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    End point title
    		 overall quality of bowel cleansing
    End point description
    End point type
    Primary
    End point timeframe
    during colonoscopy
    End point values
    		 Sodium phosphate tablets Polyethylene glycol Full analysis
    Number of subjects analysed
    219
    210
    429
    Units: number of patients with a BBPS >=7
    189
    187
    376
    Statistical analysis title
    		 primary efficacy analysis
    Statistical analysis description
    Descriptive statistics [group size, mean, standard deviations, median, ranges, and 95 % confidence intervals (CI)] were used to report patients’ baseline characteristics. The sample size was determined assuming an estimated “adequate” cleansing rate of the colon of 85 %, a 10 % non-inferiority margin, 80 % power and a one-sided significance level of 0.025.
    Comparison groups
    Sodium phosphate tablets v Polyethylene glycol
    Number of subjects included in analysis
    429
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.025
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - 10 % non-inferiority margin

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from informed consent signature till the follow up visit (7-10 days after last study drug administration)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    overall Safety population
    Reporting group description
    		 The Safety set includes all the subjects included in the study who received any study medication.

    Serious adverse events
    		 overall Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 452 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 overall Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    298 / 452 (65.93%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 452 (2.43%)
         occurrences all number
    2
    General disorders and administration site conditions
    Hyperphosphataemia
         subjects affected / exposed
    9 / 452 (1.99%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    245 / 452 (54.20%)
         occurrences all number
    54
    Nausea
         subjects affected / exposed
    142 / 452 (31.42%)
         occurrences all number
    31
    Abdominal pain
         subjects affected / exposed
    67 / 452 (14.82%)
         occurrences all number
    15
    Vomiting
         subjects affected / exposed
    44 / 452 (9.73%)
         occurrences all number
    10
    Gastritis
         subjects affected / exposed
    12 / 452 (2.65%)
         occurrences all number
    3

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27864718
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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
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