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    Clinical Trial Results:
    Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy

    Summary
    EudraCT number
    		 2019-003749-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Apr 2020
    First version publication date
    04 Apr 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BLI800-501
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02189850
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Braintree Laboratories
    Sponsor organisation address
    60 Columbian St. West, Braintree, Massachusetts, United States, 02185
    Public contact
    Medical Director, Ipsen Pharma, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen Pharma, clinical.trials@ipsen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000816-PIP02-10
    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
    14 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to compare the safety, tolerability and efficacy of the Food and Drug Administration approved split-dose adult regimen of BLI800 (i.e., two 6 ounce [oz] bottles of oral solution, each bottle containing: sodium sulfate 17.5 grams (g), potassium sulfate 3.13 g, magnesium sulfate 1.6 g) to a reduced 3/4 volume of BLI800 (4.5 oz per dose), as bowel preparations prior to colonoscopy in pediatric participants aged 12 to 17 years.
    Protection of trial subjects
    This study was conducted in full compliance to Federal Regulations (including the International Conference on Harmonization/Good Clinical Practice Guidelines and Health Insurance Portability and Accountability Act Privacy Regulations). The Investigators and all study staff conducted the study in compliance with this protocol. The Investigators were responsible for explaining the purpose, nature, and potential risks of the study to each subject. All caregivers were required to sign an informed consent form and participants of age to provide signed assent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 May 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
    United States: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    0
    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)
    32
    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
    		 This Phase 2 randomized, parallel, multi-center, open-label study was conducted at 6 study centers between 28 May 2014 and 14 January 2015 in pediatric participants requiring colonoscopy for routinely accepted indications. One study center did not enroll any participants due to the enrollment target being met.

    Pre-assignment
    Screening details
    		 A screening visit (Visit 1) was performed between 30 days to 6 days prior to colonoscopy. A total of 32 participants were screened and randomized into the study, of which 29 participants received treatment.

    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
    		 BLI800 6 oz
    Arm description
    		 Participants received BLI800 6 oz (full adult dose) oral sulfate solution on Day 0 (in evening before the day of colonoscopy) and a second 6 oz dose on the morning of Day 1 (at least 3 hours prior to the colonoscopy procedure).
    Arm type
    		 Experimental

    Investigational medicinal product name
    BLI800
    Investigational medicinal product code
    Other name
    Suprep
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    A 6 oz bottle of BLI800 oral sulfate solution containing sodium sulfate, potassium sulfate and magnesium sulfate was taken with water on Day 0 (in evening before the day of colonoscopy) and a second 6 oz bottle was taken with water on the morning of Day 1 (at least 3 hours prior to the colonoscopy procedure).

    Arm title
    		 BLI800 4.5 oz
    Arm description
    		 Participants received BLI800 4.5 oz (3/4 adult dose) oral sulfate solution on Day 0 (in evening before the day of colonoscopy) and a second 4.5 oz dose on the morning of Day 1 (at least 3 hours prior to the colonoscopy procedure).
    Arm type
    		 Experimental

    Investigational medicinal product name
    BLI800
    Investigational medicinal product code
    Other name
    Suprep
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    A 4.5 oz bottle of BLI800 oral sulfate solution containing sodium sulfate, potassium sulfate and magnesium sulfate was taken with water on Day 0 (in evening before the day of colonoscopy) and a second 4.5 oz bottle was taken with water on the morning of Day 1 (at least 3 hours prior to the colonoscopy procedure).

    Number of subjects in period 1
    		BLI800 6 oz BLI800 4.5 oz
    Started
    17
    15
    Received treatment
    16
    13
    Underwent colonoscopy procedure
    16
    12
    Completed
    14
    11
    Not completed
    3
    4
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    2
    1
         Did not receive treatment
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BLI800 6 oz
    Reporting group description
    		 Participants received BLI800 6 oz (full adult dose) oral sulfate solution on Day 0 (in evening before the day of colonoscopy) and a second 6 oz dose on the morning of Day 1 (at least 3 hours prior to the colonoscopy procedure).

    Reporting group title
    BLI800 4.5 oz
    Reporting group description
    		 Participants received BLI800 4.5 oz (3/4 adult dose) oral sulfate solution on Day 0 (in evening before the day of colonoscopy) and a second 4.5 oz dose on the morning of Day 1 (at least 3 hours prior to the colonoscopy procedure).

    Reporting group values
    		 BLI800 6 oz BLI800 4.5 oz Total
    Number of subjects
    		 17 15 32
    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)
    		 0 0 0
        Adolescents (12-17 years)
    		 17 15 32
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 10 18
        Male
    		 9 5 14
    Race
    Units: Subjects
        Black or African American
    		 4 2 6
        White
    		 13 12 25
        Other
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    BLI800 6 oz
    Reporting group description
    		 Participants received BLI800 6 oz (full adult dose) oral sulfate solution on Day 0 (in evening before the day of colonoscopy) and a second 6 oz dose on the morning of Day 1 (at least 3 hours prior to the colonoscopy procedure).

    Reporting group title
    BLI800 4.5 oz
    Reporting group description
    		 Participants received BLI800 4.5 oz (3/4 adult dose) oral sulfate solution on Day 0 (in evening before the day of colonoscopy) and a second 4.5 oz dose on the morning of Day 1 (at least 3 hours prior to the colonoscopy procedure).

    Primary: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. An AE is ‘serious’ if it: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; consists of a congenital anomaly or birth defect; requires medical or surgical intervention to prevent permanent impairment or damage. A TEAE is defined as any AE that began or worsened following start of BLI800 dosing. A treatment-related AE is defined as any TEAE that was assessed by Investigator as possibly, probably or definitely related to BLI800 solution. Intent-To-Treat (ITT) analysis set included all participants randomized that took any portion of BLI800 solution.
    End point type
    Primary
    End point timeframe
    From first administration of BLI800 solution (Day 0) up to Day 32.
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    16
    13
    Units: percentage of participants
    number (not applicable)
        Any TEAE
    81.3
    92.3
        Any Treatment-related TEAE
    68.8
    84.7
        Any SAE
    0
    0
    Statistical analysis title
    		 Treatment difference for TEAEs and SAEs
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.791
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.2
         upper limit
    		 20.1

    Primary: Percentage of Participants With Successful Preparation for Colonoscopy Procedure

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    End point title
    		 Percentage of Participants With Successful Preparation for Colonoscopy Procedure
    End point description
    The colonoscopist assessed colon cleansing using a four point scale ranging from 1 to 4. Where, 1 = poor; 2 = fair; 3 = good and 4 = excellent. Preparation success is defined as bowel cleansing graded either excellent or good. Grades 3 and 4 were considered “successful” and grades 1 and 2 were considered “failures”. The ITT analysis set included all participants randomized that took any portion of BLI800 solution. One participant in the BLI800 4.5 oz group was excluded as non-evaluable for efficacy analysis.
    End point type
    Primary
    End point timeframe
    At Day 1
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    16
    13 [1]
    Units: percentage of participants
    number (not applicable)
        Success
    81.3
    83.3
        Failure
    18.8
    16.7
    Notes
    [1] - One ITT participant was excluded as non-evaluable for efficacy analysis.
    Statistical analysis title
    		 Treatment difference for preparation success
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.923
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.6
         upper limit
    		 26.4
    Notes
    [2] - Confidence Interval (CI) for percentage success difference between treatments was from a chi-square test.

    Secondary: Investigator Grading of Residual Stool Assessment by Colon Segment

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    End point title
    		 Investigator Grading of Residual Stool Assessment by Colon Segment
    End point description
    The colonoscopist evaluated the five colonic segments for amounts of residual stool with a score ranging from 1 to 4. Where, 1 = absent; 2 = small; 3 = moderate and 4 = excess. The ITT analysis set included all participants randomized that took any portion of BLI800 solution. One participant in the BLI800 4.5 oz group was excluded as non-evaluable for efficacy analysis. Number of participants at each of the indicated grades for the five colon segments are reported.
    End point type
    Secondary
    End point timeframe
    At Day 1
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    16
    13 [3]
    Units: participants
        Stool cecum: Absent
    7
    8
        Stool cecum: Small
    5
    2
        Stool cecum: Moderate
    2
    0
        Stool cecum: Excess
    1
    1
        Stool ascending colon: Absent
    9
    9
        Stool ascending colon: Small
    4
    1
        Stool ascending colon: Moderate
    1
    1
        Stool ascending colon: Excess
    1
    0
        Stool transverse colon: Absent
    11
    10
        Stool transverse colon: Small
    2
    0
        Stool transverse colon: Moderate
    3
    1
        Stool transverse colon: Excess
    0
    0
        Stool descending colon: Absent
    11
    10
        Stool descending colon: Small
    2
    0
        Stool descending colon: Moderate
    3
    1
        Stool descending colon: Excess
    0
    1
        Stool sigmoid and rectum: Absent
    9
    8
        Stool sigmoid and rectum: Small
    5
    3
        Stool sigmoid and rectum: Moderate
    2
    0
        Stool sigmoid and rectum: Excess
    0
    1
    Notes
    [3] - One ITT participant was excluded as non-evaluable for efficacy analysis.
    Statistical analysis title
    		 Treatment difference for stool cecum
    Comparison groups
    BLI800 4.5 oz v BLI800 6 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.578
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Treatment difference for stool ascending colon
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.722
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Treatment difference for stool transverse colon
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.497
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Treatment difference for stool descending colon
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.453
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Treatment difference for stool sigmoid and rectum
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.457
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Investigator Grading of Residual Fluid Assessment by Colon Segment

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    End point title
    		 Investigator Grading of Residual Fluid Assessment by Colon Segment
    End point description
    The colonoscopist evaluated the five colonic segments for amounts of residual fluid with a score ranging from 1 to 4. Where, 1 = absent; 2 = small; 3 = moderate and 4 = excess. The ITT analysis set included all participants randomized that took any portion of BLI800 solution. One participant in the BLI800 4.5 oz group was excluded as non-evaluable for efficacy analysis. Number of participants at each of the indicated grades for the five colon segments are reported.
    End point type
    Secondary
    End point timeframe
    At Day 1
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    16
    13 [4]
    Units: participants
        Fluid cecum: Absent
    5
    4
        Fluid cecum: Small
    5
    4
        Fluid cecum: Moderate
    5
    2
        Fluid cecum: Excess
    0
    1
        Fluid ascending colon: Absent
    8
    7
        Fluid ascending colon: Small
    5
    3
        Fluid ascending colon: Moderate
    2
    1
        Fluid ascending colon: Excess
    0
    0
        Fluid transverse colon: Absent
    9
    9
        Fluid transverse colon: Small
    4
    1
        Fluid transverse colon: Moderate
    3
    1
        Fluid transverse colon: Excess
    0
    0
        Fluid descending colon: Absent
    3
    8
        Fluid descending colon: Small
    8
    2
        Fluid descending colon: Moderate
    4
    1
        Fluid descending colon: Excess
    1
    1
        Fluid sigmoid and rectum: Absent
    4
    9
        Fluid sigmoid and rectum: Small
    7
    2
        Fluid sigmoid and rectum: Moderate
    4
    0
        Fluid sigmoid and rectum: Excess
    1
    1
    Notes
    [4] - One ITT participant was excluded as non-evaluable for efficacy analysis.
    Statistical analysis title
    		 Treatment difference for fluid cecum
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.64
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Treatment difference for fluid ascending colon
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Treatment difference for fluid transverse colon
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.436
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Treatment difference for fluid descending colon
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.06
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Treatment difference for fluid sigmoid and rectum
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.032
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of Participants who had Adequate Cleansing for Evaluation

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    End point title
    		 Percentage of Participants who had Adequate Cleansing for Evaluation
    End point description
    The colonoscopist evaluated whether or not cleansing was adequate for examination. The ITT analysis set included all participants randomized that took any portion of BLI800 solution. One participant in the BLI800 4.5 oz group was excluded as non-evaluable for efficacy analysis.
    End point type
    Secondary
    End point timeframe
    At Day 1
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    16
    13
    Units: percentage of participants
    number (not applicable)
        Yes
    87.5
    83.3
        No
    12.5
    16.7
    Statistical analysis title
    		 Treatment difference for adequate cleansing
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.4
         upper limit
    		 30.8
    Notes
    [5] - The CI for percentage difference between treatments was from a chi-square test.

    Secondary: Percentage of Participants With Need for Re-Preparation

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    End point title
    		 Percentage of Participants With Need for Re-Preparation
    End point description
    The colonoscopist evaluated whether or not cleansing was adequate for examination. If the preparation was not adequate, the need for re-preparation was recorded. The ITT analysis set included all participants randomized that took any portion of BLI800 solution. One participant in the BLI800 4.5 oz group was excluded as non-evaluable for efficacy analysis. Only participants who did not have an adequate cleansing were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Day 1
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    2
    2
    Units: percentage of participants
    number (not applicable)
        Yes
    0
    0
        No
    100.0
    100.0
    No statistical analyses for this end point

    Secondary: Duration of Colonoscopy

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    End point title
    		 Duration of Colonoscopy
    End point description
    Start time and completion time of colonoscopy were recorded. The ITT analysis set included all participants randomized that took any portion of BLI800 solution. One participant in the BLI800 4.5 oz group was excluded as non-evaluable for efficacy analysis.
    End point type
    Secondary
    End point timeframe
    At Day 1
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    16
    13 [6]
    Units: minute
        arithmetic mean (standard deviation)
    19.7 ± 12.57
    26.4 ± 26.97
    Notes
    [6] - One ITT participant was excluded as non-evaluable for efficacy analysis.
    No statistical analyses for this end point

    Secondary: Volume of Intraprocedural Water Needed to Irrigate the Colon

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    End point title
    		 Volume of Intraprocedural Water Needed to Irrigate the Colon
    End point description
    Volume of water used to improve visualization was measured. The ITT analysis set included all participants randomized that took any portion of BLI800 solution. One participant in the BLI800 4.5 oz group was excluded as non-evaluable for efficacy analysis.
    End point type
    Secondary
    End point timeframe
    At Day 1
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    16
    13 [7]
    Units: milliliter
        arithmetic mean (standard deviation)
    29.4 ± 59.75
    17.9 ± 58.99
    Notes
    [7] - One ITT participant was excluded as non-evaluable for efficacy analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Procedures That Reached the Cecum

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    End point title
    		 Percentage of Participants With Procedures That Reached the Cecum
    End point description
    The colonoscopist evaluated whether or not the cecum was reached. The ITT analysis set included all participants randomized that took any portion of BLI800 solution. One participant in the BLI800 4.5 oz group was excluded as non-evaluable for efficacy analysis.
    End point type
    Secondary
    End point timeframe
    At Day 1
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    16
    13 [8]
    Units: percentage of participants
    number (not applicable)
        Yes
    93.8
    91.7
        No
    6.3
    8.3
    Notes
    [8] - One ITT participant was excluded as non-evaluable for efficacy analysis.
    Statistical analysis title
    		 Treatment difference for cecum reached
    Comparison groups
    BLI800 6 oz v BLI800 4.5 oz
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.5
         upper limit
    		 21.7
    Notes
    [9] - The CI for percentage attempted difference between treatments was from a chi-square test.

    Secondary: Time to Reach Cecum

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    End point title
    		 Time to Reach Cecum
    End point description
    Time to reach cecum was recorded. The ITT analysis set included all participants randomized that took any portion of BLI800 solution. One participant in the BLI800 4.5 oz group was excluded as non-evaluable for efficacy analysis. Only participants recorded as 'Yes' for cecum reached were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Day 1
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    15
    11
    Units: minute
        arithmetic mean (standard deviation)
    9.3 ± 9.10
    15.5 ± 25.33
    No statistical analyses for this end point

    Secondary: Percentage of Participants for Each Preparation Cleansing Grade

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    End point title
    		 Percentage of Participants for Each Preparation Cleansing Grade
    End point description
    The colonoscopist assessed colon cleansing using a four point scale ranging from 1 to 4. Where, 1 = poor; 2 = fair; 3 = good and 4 = excellent. The ITT analysis set included all participants randomized that took any portion of BLI800 solution. One participant was excluded as non-evaluable for efficacy analysis.
    End point type
    Secondary
    End point timeframe
    At Day 1
    End point values
    		 BLI800 6 oz BLI800 4.5 oz
    Number of subjects analysed
    16
    13 [10]
    Units: percentage of participant
    number (not applicable)
        Excellent
    37.5
    75.0
        Good
    43.8
    8.3
        Fair
    6.3
    8.3
        Poor
    12.5
    8.3
    Notes
    [10] - One ITT participant was excluded as non-evaluable for efficacy analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first administration of BLI800 solution (Day 0) up to Day 32.
    Adverse event reporting additional description
    The ITT analysis set included all participants randomized that took any portion of BLI800 solution.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    BLI800 6 oz
    Reporting group description
    		 Participants received BLI800 6 oz (full adult dose) oral sulfate solution on Day 0 (in evening before the day of colonoscopy) and a second 6 oz dose on the morning of Day 1 (at least 3 hours prior to the colonoscopy procedure).

    Reporting group title
    BLI800 4.5 oz
    Reporting group description
    		 Participants received BLI800 4.5 oz (3/4 adult dose) oral sulfate solution on Day 0 (in evening before the day of colonoscopy) and a second 4.5 oz dose on the morning of Day 1 (at least 3 hours prior to the colonoscopy procedure).

    Serious adverse events
    		 BLI800 6 oz BLI800 4.5 oz
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 13 (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
    		 BLI800 6 oz BLI800 4.5 oz
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 16 (81.25%)
    12 / 13 (92.31%)
    Investigations
    Bacterial test
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Liver function test abnormal
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Protein urine present
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Urinary casts
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    3
    Syncope
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Injection site pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Abdominal distention
         subjects affected / exposed
    5 / 16 (31.25%)
    8 / 13 (61.54%)
         occurrences all number
    5
    8
    Abdominal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    4
    Abdominal pain upper
         subjects affected / exposed
    5 / 16 (31.25%)
    4 / 13 (30.77%)
         occurrences all number
    5
    6
    Abdominal tenderness
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Anal fissure
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Anorectal discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    2
    Eructation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Gastric ulcer
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    8 / 16 (50.00%)
    6 / 13 (46.15%)
         occurrences all number
    8
    6
    Rectal haemorrhage
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 13 (15.38%)
         occurrences all number
    2
    3
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    2
    Infections and infestations
    Helicobacter infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Metabolic acidosis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2014
    Increased screening visit from within 6 days of colonoscopy to between 30 and 6 days prior to colonoscopy and amended study duration from up to 39 days to up to 60 days.

    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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