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    Clinical Trial Results:
    A RANDOMISED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO EVALUATE THE EFFECT OF LINACLOTIDE ON COLONIC MOTILITY ASSESSED WITH INTRALUMINAL COLONIC MANOMETRY IN HEALTHY SUBJECTS

    Summary
    EudraCT number
    		 2013-004939-73
    Trial protocol
    		 BE  
    Global end of trial date
    28 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Dec 2024
    First version publication date
    28 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LINACLOTIDEPLACEBO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TARGID UZLEUVEN KULEUVEN
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Jan Tack, KULEUVEN, 0032 16344225, jan.tack@kuleuven.be
    Scientific contact
    Jan Tack, KULEUVEN, 0032 16344225, jan.tack@kuleuven.be
    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 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to evaluate the effects of linaclotideas compared to placebo on motility index and on the number of colonic high amplitude propagated contractions (HAPCs) during a 8-hour intraluminal manometry in healthy subjects.
    Protection of trial subjects
    healthy volunteers. sedation during colonoscopy
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jan 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
    Belgium: 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
    		 healthy subjects

    Pre-assignment
    Screening details
    		 healthy subjects with a normal bowel habit No diagnosis of organic or functional gastrointestinal disease. no abdominal surgery other than appendectomy. No intake of laxatives or other medications.

    Period 1
    Period 1 title
    overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 linaclotide
    Arm description
    		 After 90 min of basal recording, linaclotide 290 µg was administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal oral intake of 290 µg linaclotide in a single administration, together with 125mL of water;
    Arm type
    		 Active comparator

    Investigational medicinal product name
    linaclotide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    oral intake of 290 µg linaclotide in a single administration, together with 125mL of water;

    Arm title
    		 placebo
    Arm description
    		 After 90 min of basal recording, placebo was administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal oral intake of placebo, consisting in an empty capsule in a single oral administration, together with 125mL of water
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On the first day of each treatment period, after a 12-h fasting period, all subjects were admitted to the Motility Unit. Bowel preparation was performed through a tap water enema. Oral intake of placebo, consisting in an empty capsule in a single oral administration, together with 125mL of water.

    Number of subjects in period 1
    		linaclotide placebo
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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

    Reporting group values
    		 overall period Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 10
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.3 ( 10.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    linaclotide
    Reporting group description
    		 After 90 min of basal recording, linaclotide 290 µg was administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal oral intake of 290 µg linaclotide in a single administration, together with 125mL of water;

    Reporting group title
    placebo
    Reporting group description
    		 After 90 min of basal recording, placebo was administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal oral intake of placebo, consisting in an empty capsule in a single oral administration, together with 125mL of water

    Primary: Colonic motility index

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    End point title
    		 Colonic motility index
    End point description
    After 90 min of basal recording, linaclotide 290 µg or placebo were administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal. Colonic motility index of the right, left colon and rectum, expressed as ratio of the baseline value was compared between treatments by means of a mixed models analysis.
    End point type
    Primary
    End point timeframe
    After 90 min of basal recording, linaclotide 290 µg or placebo were administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal.
    End point values
    		 linaclotide placebo
    Number of subjects analysed
    9 [1]
    10
    Units: Motility index
    median (inter-quartile range (Q1-Q3))
        preprandial right colon
    2.65972 (1.80597 to 4.23004)
    1.47693 (1.25567 to 1.76870)
        1h post right colon
    3.12884 (2.56553 to 4.66207)
    1.53131 (1.26702 to 2.11822)
        preprandial left colon
    1.66279 (1.62261 to 3.39836)
    1.23797 (1.13288 to 1.81045)
        1h post left colon
    2.79077 (2.35410 to 4.34425)
    1.46099 (1.31564 to 2.05882)
        preprandial rectum
    1.60144 (1.09675 to 2.51950)
    1.23251 (1.02711 to 1.57230)
        1h post rectum
    1.87186 (1.82752 to 3.21536)
    1.25801 (1.01017 to 2.04550)
    Notes
    [1] - the tracing displayed too many artifacts to be properly evaluated and therefore be reliable
    Statistical analysis title
    		 Colonic motility index
    Statistical analysis description
    Colonic motility index (MI; averaged every 15 min in the right and left colon and in the rectum, and expressed as ratio of the baseline value) of four periods (pre-prandial, first, second, and third hour after the meal) was compared between treatments by means of a mixed models analysis with post hoc t tests and Bonferroni correction.
    Comparison groups
    placebo v linaclotide
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05 [2]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [2] - Baseline MI did not differ between treatments in the right, left colon and rectum. At mixed models analysis, no treatment effect was found on the ratio of the baseline value of colonic MI in any of the region of the colon

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For each individual, corresponds to timeframe of study participation (from signing of informed consent until last visit)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events happened during this study protocol

    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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