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    Clinical Trial Results:
    Rifaximin delayed release (400 mg tablet) for the prevention of recurrent acute diverticulitis and diverticular complications. A phase II, multicenter, double-blind, placebo-controlled, randomized clinical trial.

    Summary
    EudraCT number
    		 2017-002708-28
    Trial protocol
    		 ES   DE   HU   FR   NL   GB   PT   IT   RO  
    Global end of trial date
    22 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2023
    First version publication date
    04 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    REDIV/002/17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alfasigma S.p.A.
    Sponsor organisation address
    Via ragazzi del '99, 5, Bologna, Italy,
    Public contact
    Nicola Gargano, Alfasigma SpA, nicola.gargano@alfasigma.com
    Scientific contact
    Nicola Gargano, Alfasigma SpA, nicola.gargano@alfasigma.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
    22 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to demonstrate that the rate of patients with recurrence/complications of diverticulitis is statistically different between patients treated with any of the two doses of Rifaximin-EIR and patients treated with placebo.
    Protection of trial subjects
    Before initiating the trial, Alfasigma S.p.A. and the Investigator/Institution had to obtain written and dated approval/favourable opinion for the trial protocol, the written informed consent form, the patient recruitment procedures (e.g. adverts, if applicable), and any other written information to be provided to subjects from the relevant Independent Ethic Committee(s) (IEC(s)) and the Competent Regulatory Authorities, according to rules in force in each participant country. As part of the Investigator's/Institution's written application to the IEC(s), Alfasigma S.p.A. provided the IEC(s) with a current copy of the Investigator's Brochure. When the Investigator's Brochure was updated during the trial, Alfasigma S.p.A. supplied a copy of the updated Investigator’s Brochure to the IEC(s).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 33
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Portugal: 5
    Country: Number of subjects enrolled
    Spain: 54
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Italy: 97
    Worldwide total number of subjects
    236
    EEA total number of subjects
    235
    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)
    151
    From 65 to 84 years
    85
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed in a total of 52 investigational study sites, 22 in Italy, 3 in Germany, 9 in Spain, 5 in France, 2 in The Netherlands, 1 in Poland, 5 in Romania, 1 in Portugal, 3 in Hungary and 1 in the United Kingdom.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 236
    Number of subjects completed
    		 190

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screeining failure: 40
    Reason: Number of subjects
    		 subjects not dosed: 6
    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
    		 SAF Rifaximin EIR 400 mg
    Arm description
    		 Safety (SAF) analysis set, defined as all randomized patients who signed informed consent and took at least one dose of the investigational product Rifaximin EIR 400 mg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rifaximin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rifaximin-EIR 400 mg b.i.d. for 10 consecutive days a month, for 12 months

    Arm title
    		 SAF Rifaximin EIR 800 mg
    Arm description
    		 Safety (SAF) analysis set, defined as all randomized patients who signed informed consent and took at least one dose of the investigational product - Rifaximin EIR 800 mg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rifaximin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rifaximin-EIR 800 mg b.i.d. for 10 consecutive days a month, for 12 months

    Arm title
    		 SAF Placebo
    Arm description
    		 Safety (SAF) analysis set, defined as all randomized patients who signed informed consent and took at least one dose of the investigational product - Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for 10 consecutive days a month, for 12 months.

    Number of subjects in period 1 [1]
    		SAF Rifaximin EIR 400 mg SAF Rifaximin EIR 800 mg SAF Placebo
    Started
    63
    62
    65
    Completed
    42
    41
    47
    Not completed
    21
    21
    18
         subjects not dosed
    3
    2
    1
         Subjects who prematurely discontinuated
    18
    19
    17
    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: Demographic data and other baseline characteristics were presented for the SAF analysis set by treatment group.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SAF Rifaximin EIR 400 mg
    Reporting group description
    		 Safety (SAF) analysis set, defined as all randomized patients who signed informed consent and took at least one dose of the investigational product Rifaximin EIR 400 mg

    Reporting group title
    SAF Rifaximin EIR 800 mg
    Reporting group description
    		 Safety (SAF) analysis set, defined as all randomized patients who signed informed consent and took at least one dose of the investigational product - Rifaximin EIR 800 mg

    Reporting group title
    SAF Placebo
    Reporting group description
    		 Safety (SAF) analysis set, defined as all randomized patients who signed informed consent and took at least one dose of the investigational product - Placebo

    Reporting group values
    		 SAF Rifaximin EIR 400 mg SAF Rifaximin EIR 800 mg SAF Placebo Total
    Number of subjects
    		 63 62 65 190
    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)
    		 59.2 ± 11.1 57.9 ± 12.3 58.6 ± 10.9 -
    Gender categorical
    Units: Subjects
        Female
    		 29 31 38 98
        Male
    		 34 31 27 92

    End points

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    End points reporting groups
    Reporting group title
    SAF Rifaximin EIR 400 mg
    Reporting group description
    		 Safety (SAF) analysis set, defined as all randomized patients who signed informed consent and took at least one dose of the investigational product Rifaximin EIR 400 mg

    Reporting group title
    SAF Rifaximin EIR 800 mg
    Reporting group description
    		 Safety (SAF) analysis set, defined as all randomized patients who signed informed consent and took at least one dose of the investigational product - Rifaximin EIR 800 mg

    Reporting group title
    SAF Placebo
    Reporting group description
    		 Safety (SAF) analysis set, defined as all randomized patients who signed informed consent and took at least one dose of the investigational product - Placebo

    Subject analysis set title
    ITT Rifaximin EIR 400 mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-to-Treat (ITT) analysis set, defined as all patients of the SAF set with at least one week of data filled in the patient’s diary -Rifaximin EIR 400 mg

    Subject analysis set title
    ITT Rifaximin EIR 800 mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-to-Treat (ITT) analysis set, defined as all patients of the SAF set with at least one week of data filled in the patient’s diary -Rifaximin EIR 800 mg

    Subject analysis set title
    ITT Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-to-Treat (ITT) analysis set, defined as all patients of the SAF set with at least one week of data filled in the patient’s diary - Placebo

    Primary: Rate of patients with recurrence of diverticulitis or diverticular complications over the 12-month treatment period

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    End point title
    		 Rate of patients with recurrence of diverticulitis or diverticular complications over the 12-month treatment period
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 ITT Rifaximin EIR 400 mg ITT Rifaximin EIR 800 mg ITT Placebo
    Number of subjects analysed
    61
    59
    62
    Units: number of patients
        number (not applicable)
    10
    7
    6
    Statistical analysis title
    		 Analysis of primary variables
    Comparison groups
    ITT Rifaximin EIR 400 mg v ITT Rifaximin EIR 800 mg v ITT Placebo
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Rifaximin 400 mg
    Reporting group description
    		 -

    Reporting group title
    Rifaximin 800 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Rifaximin 400 mg Rifaximin 800 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 63 (6.35%)
    1 / 62 (1.61%)
    2 / 65 (3.08%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Pelvic fracture
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Removal of foreign body
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticular perforation
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Allergic cough
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Rifaximin 400 mg Rifaximin 800 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 63 (55.56%)
    31 / 62 (50.00%)
    42 / 65 (64.62%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    2
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    1
    0
    Hypertensive crisis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Thrombophlebitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    2
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    1
    Fatigue
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Feeling hot
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Malaise
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    3
    0
    0
    Pain
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    2 / 63 (3.17%)
    2 / 62 (3.23%)
    3 / 65 (4.62%)
         occurrences all number
    2
    3
    3
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Ovarian cyst
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Prostatitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Cough
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    2 / 65 (3.08%)
         occurrences all number
    0
    1
    2
    Dyspnoea
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    1
    0
    1
    Nasal polyps
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    2 / 65 (3.08%)
         occurrences all number
    1
    0
    2
    Anxiety disorder
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Apathy
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Somatic symptom disorder
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Urea Increased
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Breath Sounds Abnormal
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    C-Reactive Protein Increased
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Faecal Calprotectin Increased
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    3 / 65 (4.62%)
         occurrences all number
    0
    0
    3
    Helicobacter Test Positive
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Prostatic Specific Antigen Increased
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Urinary tract infection
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 62 (3.23%)
    3 / 65 (4.62%)
         occurrences all number
    2
    2
    3
    Accident at home
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    1
    0
    head injury
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Intentional product misuse
         subjects affected / exposed
    3 / 63 (4.76%)
    1 / 62 (1.61%)
    2 / 65 (3.08%)
         occurrences all number
    3
    1
    2
    Limb injury
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    1
    0
    Muscle strain
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Patella fracture
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Product dispensing error
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Radius fracture
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Cardiac fibrillation
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Palpitations
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
    0 / 65 (0.00%)
         occurrences all number
    0
    2
    0
    Facial paralysis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
    1 / 65 (1.54%)
         occurrences all number
    0
    2
    1
    Migraine
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
    1 / 65 (1.54%)
         occurrences all number
    0
    3
    1
    Piriformis syndrome
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    2
    Sciatica
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    2 / 65 (3.08%)
         occurrences all number
    0
    0
    3
    Syncope
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Normocytic anaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Thrombocytosis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    2
    Vitreous detachment
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 63 (4.76%)
    2 / 62 (3.23%)
    4 / 65 (6.15%)
         occurrences all number
    6
    2
    7
    Abdominal pain
         subjects affected / exposed
    11 / 63 (17.46%)
    9 / 62 (14.52%)
    10 / 65 (15.38%)
         occurrences all number
    16
    17
    17
    Abdominal pain lower
         subjects affected / exposed
    3 / 63 (4.76%)
    4 / 62 (6.45%)
    4 / 65 (6.15%)
         occurrences all number
    6
    10
    7
    Abdominal pain upper
         subjects affected / exposed
    3 / 63 (4.76%)
    3 / 62 (4.84%)
    3 / 65 (4.62%)
         occurrences all number
    5
    4
    3
    Abdominal tenderness
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    2
    Anal pruritus
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    4 / 63 (6.35%)
    7 / 62 (11.29%)
    5 / 65 (7.69%)
         occurrences all number
    4
    14
    8
    Diarrhoea
         subjects affected / exposed
    2 / 63 (3.17%)
    2 / 62 (3.23%)
    5 / 65 (7.69%)
         occurrences all number
    2
    4
    5
    Dyspepsia
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
    5 / 65 (7.69%)
         occurrences all number
    2
    3
    6
    Enteritis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    1
    0
    1
    Faecaloma
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Faeces soft
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 62 (0.00%)
    2 / 65 (3.08%)
         occurrences all number
    3
    0
    2
    Gastritis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    1
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Hiatus hernia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Infrequent bowel movements
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    2 / 63 (3.17%)
    3 / 62 (4.84%)
    1 / 65 (1.54%)
         occurrences all number
    2
    3
    1
    Oesophagitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Peptic ulcer
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    1
    0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic Steatosis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Alopecia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Skin disorder
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Renal colic
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 62 (0.00%)
    4 / 65 (6.15%)
         occurrences all number
    2
    0
    4
    Back pain
         subjects affected / exposed
    2 / 63 (3.17%)
    2 / 62 (3.23%)
    3 / 65 (4.62%)
         occurrences all number
    2
    2
    3
    Fibromyalgia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    1
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Plantar fasciitis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Tendonitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
    2 / 65 (3.08%)
         occurrences all number
    1
    2
    2
    Cystitis
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
    1 / 65 (1.54%)
         occurrences all number
    0
    3
    1
    Diverticulitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    1
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Helicobacter infection
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Hordeolum
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    2
    Influenza
         subjects affected / exposed
    4 / 63 (6.35%)
    1 / 62 (1.61%)
    3 / 65 (4.62%)
         occurrences all number
    4
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Testicular abscess
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
    1 / 65 (1.54%)
         occurrences all number
    0
    2
    1
    Urinary tract infection viral
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    0
    1
    Hypovitaminosis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Nov 2018
    Main substantial amendment: Amendment to on exclusion criterion

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Nov 2019
    Recruitment rate was slower than expected.
    -

    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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