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    Clinical Trial Results:
    Double blind, randomized, placebo-controlled, parallel group study to evaluate the effect of a 4-week treatment with oral doses of MEN15596 in irritable bowel syndrome.

    Summary
    EudraCT number
    		 2008-000214-71
    Trial protocol
    		 GB   ES   SK   LV   DE   DK   IT  
    Global end of trial date
    18 Feb 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2019
    First version publication date
    09 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NAK-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00761007
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LABORATORIOS MENARINI, S.A. (Menarini Group)
    Sponsor organisation address
    Alfonso XII, 587, BADALONA (BARCELONA), Spain, 08918
    Public contact
    Dr. Isabel Paredes, LABORATORIOS MENARINI, S.A. (Menarini Group), 34 934628800, iparedes@menarini.es
    Scientific contact
    Dr. Isabel Paredes, LABORATORIOS MENARINI, S.A. (Menarini Group), 34 934628800, iparedes@menarini.es
    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
    15 Mar 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Feb 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Feb 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of three doses of MEN 15596 on IBS symptoms relief as compared to placebo in the broad population of irritable bowel syndrome (IBS) patients following a 4 week oral treatment.
    Protection of trial subjects
    If any event(s) related to the conduct of the study or the development of the IMP which affected the safety of the study participants, the sponsor and the investigator were to take appropriate urgent safety measures to protect the patients against any immediate hazard. The CAs and IRB/ECs were to be informed forthwith about these new events and the measures taken. For patients participating in the study, the Sponsor had stipulated an insurance policy in accordance with local regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 22
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    United Kingdom: 52
    Country: Number of subjects enrolled
    Denmark: 148
    Country: Number of subjects enrolled
    Germany: 80
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Latvia: 72
    Country: Number of subjects enrolled
    Russian Federation: 72
    Country: Number of subjects enrolled
    Ukraine: 88
    Worldwide total number of subjects
    554
    EEA total number of subjects
    394
    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)
    508
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient in (screening) 15th July 2008, last patient out 18th February 2009.

    Pre-assignment
    Screening details
    		 The study design included a 2-week run-in period, starting from Screening on Day -14 until Day – 1 (start of the treatment).

    Period 1
    Period 1 title
    overall trial (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
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo oral film-coated tablet, (three tablets), once daily in the morning.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo oral film-coated tablet, (three tablets), once daily in the morning.

    Arm title
    		 Ibodutant 10mg
    Arm description
    		 Ibodutant 10mg, oral film-coated tablet, three tablets (one ibodutant 10 mg tablet plus two placebo tablets), once daily in the morning.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibodutant
    Investigational medicinal product code
    MEN15596
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibodutant 10 mg: oral film-coated tablet, three tablets (one ibodutant 10 mg tablet plus two placebo tablets), once daily in the morning.

    Arm title
    		 Ibodutant 30mg
    Arm description
    		 Ibodutant 30mg, oral film-coated tablet, three tablets (one ibodutant 30 mg tablet plus two placebo tablets), once daily in the morning.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibodutant
    Investigational medicinal product code
    MEN15596
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibodutant 30mg, oral film-coated tablet, three tablets (one ibodutant 30 mg tablet plus two placebo tablets), once daily in the morning.

    Arm title
    		 Ibodutant 60mg
    Arm description
    		 Ibodutant 60mg, oral film-coated tablet, three tablets (one ibodutant 60 mg tablet plus two placebo tablets), once daily in the morning.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibodutant
    Investigational medicinal product code
    MEN15596
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibodutant 60mg, oral film-coated tablet, three tablets (one ibodutant 60 mg tablet plus two placebo tablets), once daily in the morning.

    Number of subjects in period 1 [1]
    		Placebo Ibodutant 10mg Ibodutant 30mg Ibodutant 60mg
    Started
    136
    140
    133
    135
    Completed
    114
    117
    112
    112
    Not completed
    22
    23
    21
    23
         Protocol deviation
    22
    23
    21
    23
    Notes
    [1] - 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: Overall, 763 patients were screened. Among them, 554 were randomised to receive the study drug and therefore considered as enrolled. 3 patients did not take any dose of study drug, and 7 more patients who did take medication withdrew their consent. Intention to treat (ITT) population was composed of 544 patients. ITT were all patients of the Safety population who had at least one response to the binary question after randomisation.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo oral film-coated tablet, (three tablets), once daily in the morning.

    Reporting group title
    Ibodutant 10mg
    Reporting group description
    		 Ibodutant 10mg, oral film-coated tablet, three tablets (one ibodutant 10 mg tablet plus two placebo tablets), once daily in the morning.

    Reporting group title
    Ibodutant 30mg
    Reporting group description
    		 Ibodutant 30mg, oral film-coated tablet, three tablets (one ibodutant 30 mg tablet plus two placebo tablets), once daily in the morning.

    Reporting group title
    Ibodutant 60mg
    Reporting group description
    		 Ibodutant 60mg, oral film-coated tablet, three tablets (one ibodutant 60 mg tablet plus two placebo tablets), once daily in the morning.

    Reporting group values
    		 Placebo Ibodutant 10mg Ibodutant 30mg Ibodutant 60mg Total
    Number of subjects
    		 136 140 133 135 544
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.7 ± 13.73 43.9 ± 13.43 45 ± 12.66 44.4 ± 12.97 -
    Gender categorical
    Units: Subjects
        Female
    		 94 104 79 90 367
        Male
    		 42 36 54 45 177
    Race
    Units: Subjects
        Caucasian
    		 135 140 131 134 540
        Black
    		 1 0 2 1 4

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo oral film-coated tablet, (three tablets), once daily in the morning.

    Reporting group title
    Ibodutant 10mg
    Reporting group description
    		 Ibodutant 10mg, oral film-coated tablet, three tablets (one ibodutant 10 mg tablet plus two placebo tablets), once daily in the morning.

    Reporting group title
    Ibodutant 30mg
    Reporting group description
    		 Ibodutant 30mg, oral film-coated tablet, three tablets (one ibodutant 30 mg tablet plus two placebo tablets), once daily in the morning.

    Reporting group title
    Ibodutant 60mg
    Reporting group description
    		 Ibodutant 60mg, oral film-coated tablet, three tablets (one ibodutant 60 mg tablet plus two placebo tablets), once daily in the morning.

    Primary: Response (50% rule) at week 4

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    End point title
    		 Response (50% rule) at week 4
    End point description
    The response for relief of overall IBS symptoms was measured at the end of 4 weeks of treatment, where response was defined as at least two weeks with satisfactory relief during four weeks of treatment (50% rule).
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    		 Placebo Ibodutant 10mg Ibodutant 30mg Ibodutant 60mg
    Number of subjects analysed
    136 [1]
    140 [2]
    133 [3]
    135 [4]
    Units: 544
        number (not applicable)
    78
    79
    61
    61
    Notes
    [1] - Total number of subjects analysed. Number (not applicable) stands for responders.
    [2] - Total number of subjects analysed. Number (not applicable) stands for responders.
    [3] - Total number of subjects analysed. Number (not applicable) stands for responders.
    [4] - Total number of subjects analysed. Number (not applicable) stands for responders.
    Statistical analysis title
    		 Mantel-Haenzel Chi2 Statistics
    Comparison groups
    Ibodutant 10mg v Ibodutant 30mg v Ibodutant 60mg
    Number of subjects included in analysis
    408
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 Mantel-Haenszel
    Confidence interval

    Secondary: Response (75% rule) at week 4.

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    End point title
    		 Response (75% rule) at week 4.
    End point description
    The response for relief of overall IBS symptoms were measured at the end of 4 weeks of treatment, where response was defined as at least three weeks with satisfactory relief during four weeks of treatment (75% rule).
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Placebo Ibodutant 10mg Ibodutant 30mg Ibodutant 60mg
    Number of subjects analysed
    136 [5]
    140 [6]
    133 [7]
    135 [8]
    Units: 544
        number (not applicable)
    48
    53
    39
    37
    Notes
    [5] - Total number of subjects analysed. Number (not applicable) stands for responders.
    [6] - Total number of subjects analysed. Number (not applicable) stands for responders.
    [7] - Total number of subjects analysed. Number (not applicable) stands for responders.
    [8] - Total number of subjects analysed. Number (not applicable) stands for responders.
    Statistical analysis title
    		 Mantel-Haenszel Chi 2 Statistics
    Comparison groups
    Ibodutant 10mg v Ibodutant 30mg v Ibodutant 60mg
    Number of subjects included in analysis
    408
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1+/-3 days
    Adverse event reporting additional description
    Analyzed for the Safety population (all patients who received study treatment)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo oral film-coated tablet, (three tablets), once daily in the morning, before breakfast (in fasting condition).

    Reporting group title
    MEN15596 10mg
    Reporting group description
    		 MEN15596 10mg, oral film-coated tablet, three tablets (only one being MEN15596 10mg), once daily in the morning, before breakfast (in fasting condition).

    Reporting group title
    MEN15596 30mg
    Reporting group description
    		 MEN15596 30mg, oral film-coated tablet, three tablets (only one being MEN15596 30mg), once daily in the morning, before breakfast (in fasting condition).

    Reporting group title
    MEN15596 60mg
    Reporting group description
    		 MEN15596 60mg, oral film-coated tablet, three tablets (only one being MEN15596 60mg), once daily in the morning, before breakfast (in fasting condition).

    Serious adverse events
    		 Placebo MEN15596 10mg MEN15596 30mg MEN15596 60mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 137 (0.00%)
    0 / 140 (0.00%)
    3 / 135 (2.22%)
    1 / 139 (0.72%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    0 / 137 (0.00%)
    0 / 140 (0.00%)
    1 / 135 (0.74%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrilation
         subjects affected / exposed
    0 / 137 (0.00%)
    0 / 140 (0.00%)
    0 / 135 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 137 (0.00%)
    0 / 140 (0.00%)
    1 / 135 (0.74%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    0 / 137 (0.00%)
    0 / 140 (0.00%)
    1 / 135 (0.74%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo MEN15596 10mg MEN15596 30mg MEN15596 60mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 137 (32.85%)
    44 / 140 (31.43%)
    45 / 135 (33.33%)
    44 / 139 (31.65%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 140 (0.71%)
    5 / 135 (3.70%)
    2 / 139 (1.44%)
         occurrences all number
    0
    1
    5
    2
    Headache
         subjects affected / exposed
    8 / 137 (5.84%)
    9 / 140 (6.43%)
    7 / 135 (5.19%)
    5 / 139 (3.60%)
         occurrences all number
    10
    12
    10
    6
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 137 (1.46%)
    2 / 140 (1.43%)
    1 / 135 (0.74%)
    3 / 139 (2.16%)
         occurrences all number
    2
    2
    1
    3
    Urinary tract infection
         subjects affected / exposed
    0 / 137 (0.00%)
    3 / 140 (2.14%)
    3 / 135 (2.22%)
    1 / 139 (0.72%)
         occurrences all number
    0
    3
    3
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 137 (0.73%)
    4 / 140 (2.86%)
    5 / 135 (3.70%)
    5 / 139 (3.60%)
         occurrences all number
    1
    5
    5
    5
    Abdominal pain upper
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 140 (0.00%)
    1 / 135 (0.74%)
    3 / 139 (2.16%)
         occurrences all number
    2
    0
    1
    4
    Diarrhoea
         subjects affected / exposed
    3 / 137 (2.19%)
    5 / 140 (3.57%)
    1 / 135 (0.74%)
    2 / 139 (1.44%)
         occurrences all number
    3
    5
    1
    3
    Dyspepsia
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 140 (1.43%)
    2 / 135 (1.48%)
    3 / 139 (2.16%)
         occurrences all number
    1
    2
    12
    3
    Flatulence
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 140 (0.00%)
    1 / 135 (0.74%)
    3 / 139 (2.16%)
         occurrences all number
    2
    0
    1
    3
    Nausea
         subjects affected / exposed
    4 / 137 (2.92%)
    5 / 140 (3.57%)
    6 / 135 (4.44%)
    3 / 139 (2.16%)
         occurrences all number
    5
    5
    7
    3
    Vomiting
         subjects affected / exposed
    3 / 137 (2.19%)
    1 / 140 (0.71%)
    0 / 135 (0.00%)
    1 / 139 (0.72%)
         occurrences all number
    4
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 137 (0.73%)
    3 / 140 (2.14%)
    1 / 135 (0.74%)
    1 / 139 (0.72%)
         occurrences all number
    1
    3
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 137 (1.46%)
    3 / 140 (2.14%)
    1 / 135 (0.74%)
    2 / 139 (1.44%)
         occurrences all number
    2
    3
    1
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 137 (5.11%)
    5 / 140 (3.57%)
    6 / 135 (4.44%)
    4 / 139 (2.88%)
         occurrences all number
    9
    6
    7
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Oct 2008
    There were 3 protocol amendments but just one of them was substantial to the Final Protocol (Amendment nº 3) that affected the conditions for subject’s participation in the trial, the Patient Information Leaflet/Informed Consent Form (PIL/ICF) was accordingly amended to incorporate this modification and participating subjects were required to consider and sign the amended version indicating that they re-consented to participate in the trial.

    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
    For support, Contact us.
    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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