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    Clinical Trial Results:
    Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease

    Summary
    EudraCT number
    		 2006-000720-13
    Trial protocol
    		 DE   AT   DK   CZ  
    Global end of trial date
    18 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Sep 2016
    First version publication date
    25 Sep 2016
    Other versions
    Summary report(s)
    		 Study Report Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    TSU-2/CDA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01279577
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstrasse 5, Freiburg, Germany, 79108
    Public contact
    Department of Medical Science, Dr Falk Pharma GmbH, ++49 761-1514-0,
    Scientific contact
    Department of Medical Science, Dr Falk Pharma GmbH, ++49 761-1514-0,
    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
    30 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn’s disease.
    Protection of trial subjects
    Prior to recruitment of patients, all relevant documents of the clinical study were submitted and approved by the Independent Ethics Committees (IECs) responsible for the participating investigators. Written consent documents embodied the elements of informed consent as described in the Declaration of Helsinki, the ICH Guidelines for Good Clinical Practice (GCP) and were in accordance with all applicable laws and regulations. The informed consent form and patient information sheet described the planned and permitted uses, transfers and disclosures of the patient’s personal data and personal health information for purposes of conducting the study. The informed consent form and the patient information sheet further explained the nature of the study, its objectives and potential risks and benefits as well as the date informed consent was given. Before being enrolled in the clinical trial, every patient was informed that participation in this trial was voluntary and that he/she could withdraw from the study at any time without giving a reason and without having to fear any loss in his/her medical care. The patient’s consent was obtained in writing before the start of the study. By signing the informed consent, the patient declared that he/she was participating voluntarily and intended to follow the study protocol instructions and the instructions of the investigator and to answer the questions asked during the course of the trial. For colonoscopy and biopsy sampling to be performed for confirmation of diagnosis of collagenous colitis by the central pathologist, the patients received the standard preparation for bowel cleansing and sedation during the colonoscopy as routinely performed at the study sites.
    Background therapy
    		 No concomitant background therapy, except stable dosing with oral mesalazine, was allowed during the trial.
    Evidence for comparator
    		 Using a placebo arm in this clinical trial as reference was ethically justified and in accordance with Article 29 of the Declaration of Helsinki (2008), as there were compelling and scientifically sound methodological reasons for the use of a placebo control in this trial, since this was a proof-of-concept study for induction of clinical remission with TSO in mild-moderately active Crohn's disease patients.
    Actual start date of recruitment
    16 Nov 2010
    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
    Austria: 8
    Country: Number of subjects enrolled
    Czech Republic: 11
    Country: Number of subjects enrolled
    Denmark: 10
    Country: Number of subjects enrolled
    Germany: 188
    Country: Number of subjects enrolled
    Switzerland: 35
    Worldwide total number of subjects
    252
    EEA total number of subjects
    217
    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)
    249
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This clinical trial was conducted in 53 sites in 5 countries: 1 center in Austria, 5 centers in the Czech Republic, 2 centers in Denmark, 43 centers in Germany, and 2 centers in Switzerland. First patient was screened (entered) at the 16 Nov 2010. Last patient completed his last visit at 18 Feb 2014

    Pre-assignment
    Screening details
    		 446 patients were screened to fullfill the In-/Exclusion criteria. Of them, 252 patients were randomized and treated with TSO or placebo.

    Pre-assignment period milestones
    Number of subjects started
    		 446 [1]
    Number of subjects completed
    		 252

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 194
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 446 patients were screened. During screening, the In/Exclusion criteria with regard to laboratory and clinical signs of disease activity were prospectively checked: 252 patients had a proof of active inflammatory Crohn's disease and were subsequently randomized and treated in the double-blind phase.
    Period 1
    Period 1 title
    Double-blind 12-week treatment phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The appearance and taste of the placebo solution was indistinguishable from the verum TSO suspension.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo solution (15 ml/day) fortnightly (6-times)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo solution
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    15ml placebo solution/bottle to be administered fortnightly (i.e., every 2 weeks) 6-times during the treatment period

    Arm title
    		 TSO 250
    Arm description
    		 Suspension of 250 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase
    Arm type
    		 Experimental

    Investigational medicinal product name
    Suspension of 250 embryonated, viable TSO/15 ml
    Investigational medicinal product code
    TSO 250
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Suspension of 250 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase

    Arm title
    		 TSO 2.500
    Arm description
    		 Suspension of 2.500 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase
    Arm type
    		 Experimental

    Investigational medicinal product name
    Suspension of 250 embryonated, viable TSO/15 ml/day
    Investigational medicinal product code
    TSO 2.500
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Suspension of 2.500 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase

    Arm title
    		 TSO 7.500
    Arm description
    		 Suspension of 7.500 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase
    Arm type
    		 Experimental

    Investigational medicinal product name
    Suspension of 7.500 embryonated, viable TSO/15 ml/day fortnightly
    Investigational medicinal product code
    TSO 7.500
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Suspension of 7.500 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase

    Number of subjects in period 1
    		Placebo TSO 250 TSO 2.500 TSO 7.500
    Started
    70
    39
    71
    72
    Completed
    51
    27
    51
    55
    Not completed
    19
    12
    20
    17
         Consent withdrawn by subject
    1
    2
    3
    4
         Forbidden concomitant treatment with antibiotics
    1
    1
    -
    -
         Adverse event, non-fatal
    1
    2
    1
    1
         Pregnancy
    -
    -
    -
    2
         Lack of efficacy
    16
    7
    16
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo solution (15 ml/day) fortnightly (6-times)

    Reporting group title
    TSO 250
    Reporting group description
    		 Suspension of 250 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase

    Reporting group title
    TSO 2.500
    Reporting group description
    		 Suspension of 2.500 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase

    Reporting group title
    TSO 7.500
    Reporting group description
    		 Suspension of 7.500 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase

    Reporting group values
    		 Placebo TSO 250 TSO 2.500 TSO 7.500 Total
    Number of subjects
    		 70 39 71 72 252
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 69 39 70 71 249
        From 65-84 years
    		 1 0 1 1 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.7 ( 12.8 ) 37.8 ( 9.5 ) 37.8 ( 11 ) 34.8 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 44 20 42 48 154
        Male
    		 26 19 29 24 98
    Ethnic Group
    Units: Subjects
        White
    		 70 39 70 70 249
        Hispanic
    		 0 0 0 1 1
        Arabic
    		 0 0 1 0 1
        Inuit
    		 0 0 0 1 1
    Smoking status
    Units: Subjects
        Current smoker
    		 18 14 20 21 73
        Former smoker
    		 22 10 23 18 73
        Non-smoker
    		 30 15 28 33 106
    Disease Localization
    Units: Subjects
        Ileocecal
    		 37 18 34 38 127
        Ileocolonic
    		 14 12 16 16 58
        Colonic
    		 12 9 13 12 46
        Missing
    		 7 0 8 6 21
    Concomitant mesalamine treatment
    Units: Subjects
        yes
    		 12 9 16 17 54
        no
    		 58 30 55 55 198
    Stool Calprotectin >5x ULN at Baseline
    Units: Subjects
        Yes
    		 49 29 58 50 186
        no
    		 21 10 13 22 66
    CRP > 2x ULN at Baseline
    Units: Subjects
        Yes
    		 38 17 32 41 128
        No
    		 32 22 39 31 124
    BMI
    Units: kg/squaremeter
        arithmetic mean (standard deviation)
    		 24.2 ( 4.4 ) 23.1 ( 4.2 ) 24.5 ( 4.6 ) 24.9 ( 5.9 ) -
    CDAI at Baseline
    Units: Points
        arithmetic mean (standard deviation)
    		 271 ( 47 ) 267 ( 40 ) 266 ( 39 ) 271 ( 47 ) -
    Stool calprotectin at Baseline
    Units: µg/g stool
        arithmetic mean (standard deviation)
    		 1146 ( 1846 ) 1073 ( 1473 ) 1614 ( 2115 ) 1452 ( 2226 ) -
    Disease duration
    Units: Years
        arithmetic mean (standard deviation)
    		 9.5 ( 7.4 ) 8 ( 6.8 ) 7.9 ( 7.8 ) 6.4 ( 6.4 ) -
    CRP
    Units: mg/ml
        median (full range (min-max))
    		 10.8 (0.1 to 150.8) 6.9 (0.1 to 99.9) 8.8 (0.1 to 135.5) 12.8 (0.1 to 121.2) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo solution (15 ml/day) fortnightly (6-times)

    Reporting group title
    TSO 250
    Reporting group description
    		 Suspension of 250 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase

    Reporting group title
    TSO 2.500
    Reporting group description
    		 Suspension of 2.500 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase

    Reporting group title
    TSO 7.500
    Reporting group description
    		 Suspension of 7.500 embryonated, viable TSO/15 ml/day fortnightly (i.e., every 2 weeks), 6 times during treatment phase

    Primary: Number (%) of patients with clinical remission (CDAI <150)

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    End point title
    		 Number (%) of patients with clinical remission (CDAI <150)
    End point description
    Number (%) of patients with clinical remission defined as a Clinical Disease Activity Index (according to Best) of <150 points at week 12 (last observation carried forward)
    End point type
    Primary
    End point timeframe
    at Week 12 (LOCF)
    End point values
    		 Placebo TSO 250 TSO 2.500 TSO 7.500
    Number of subjects analysed
    70
    39
    71
    72
    Units: Number of patients
    30
    15
    25
    34
    Statistical analysis title
    		 Final Analysis (FAS): TSO 250 vs placebo
    Comparison groups
    Placebo v TSO 250
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.6725 [2]
    Method
    		 Normal approximation test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.044
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.236
         upper limit
    		 0.148
    Notes
    [1] - Test for superiority of TSO 250 versus placebo. Normal approximation tests for rates were used to test the three null hypotheses on each step against their alternative hypotheses. In order to adjust for multiplicity, a closed testing procedure with the Simes intersection test was employed for hypothesis testing on each step. For confirmatory hypothesis testing the inverse normal method of combining the p-values of the normal approximation.
    [2] - Testing of H0 (πPla > πTSO250) by means of the normal approximation test for rates (α = 0.025 one-sided). A closed testing procedure with the Simes intersection test was used toadjust for multiplicity testing of all TSO groups versus placebo
    Statistical analysis title
    		 Final Analysis (FAS): TSO 2.500 vs placebo
    Comparison groups
    Placebo v TSO 2.500
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.824 [4]
    Method
    		 Normal approximation test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.076
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.237
         upper limit
    		 0.084
    Notes
    [3] - Test for superiority of TSO 2.500 versus placebo. Normal approximation tests for rates were used to test the three null hypotheses on each step against their alternative hypotheses. In order to adjust for multiplicity, a closed testing procedure with the Simes intersection test was employed for hypothesis testing on each step. For confirmatory hypothesis testing the inverse normal method of combining the p-values of the normal approximation.
    [4] - Testing of H0 (πPla > πTSO2.500) by means of the normal approximation test for rates (α = 0.025 one-sided). A closed testing procedure with the Simes intersection test was used toadjust for multiplicity testing of all TSO groups versus placebo
    Statistical analysis title
    		 Final Analysis (FAS): TSO 7.500 vs placebo
    Comparison groups
    Placebo v TSO 7.500
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.3006 [6]
    Method
    		 Normal approximation test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.044
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.207
    Notes
    [5] - Test for superiority of TSO 7.500 versus placebo. Normal approximation tests for rates were used to test the three null hypotheses on each step against their alternative hypotheses. In order to adjust for multiplicity, a closed testing procedure with the Simes intersection test was employed for hypothesis testing on each step. For confirmatory hypothesis testing the inverse normal method of combining the p-values of the normal approximation.
    [6] - Testing of H0 (πPla > πTSO7.500) by means of the normal approximation test for rates (α = 0.025 one-sided). A closed testing procedure with the Simes intersection test was used toadjust for multiplicity testing of all TSO groups versus placebo

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    TSO 250
    Reporting group description
    		 -

    Reporting group title
    TSO 2.500
    Reporting group description
    		 -

    Reporting group title
    TSO 7.500
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo TSO 250 TSO 2.500 TSO 7.500
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 70 (17.14%)
    2 / 39 (5.13%)
    4 / 71 (5.63%)
    8 / 72 (11.11%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Surgical and medical procedures
    Intestinal resection
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    1 / 71 (1.41%)
    0 / 72 (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
    Tonsillectomy
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    1 / 72 (1.39%)
         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
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease deterioration
         subjects affected / exposed
    3 / 70 (4.29%)
    1 / 39 (2.56%)
    0 / 71 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 39 (2.56%)
    0 / 71 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileal stenosis
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    1 / 71 (1.41%)
    0 / 72 (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
    Rectal haemorrhage
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    1 / 72 (1.39%)
         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
    Small intestinal stenosis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Granuloma skin
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    1 / 72 (1.39%)
         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
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    1 / 71 (1.41%)
    0 / 72 (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
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fistula
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    1 / 72 (1.39%)
         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
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    1 / 72 (1.39%)
         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
    Infections and infestations
    Pyelocystitis
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    1 / 71 (1.41%)
    0 / 72 (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
    Sinusitis
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    1 / 72 (1.39%)
         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
    Anal abscess
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 39 (0.00%)
    0 / 71 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo TSO 250 TSO 2.500 TSO 7.500
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 70 (75.71%)
    28 / 39 (71.79%)
    56 / 71 (78.87%)
    54 / 72 (75.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 70 (11.43%)
    10 / 39 (25.64%)
    13 / 71 (18.31%)
    13 / 72 (18.06%)
         occurrences all number
    8
    11
    13
    16
    Dizzine
         subjects affected / exposed
    2 / 70 (2.86%)
    2 / 39 (5.13%)
    1 / 71 (1.41%)
    3 / 72 (4.17%)
         occurrences all number
    2
    2
    1
    3
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 70 (0.00%)
    2 / 39 (5.13%)
    1 / 71 (1.41%)
    0 / 72 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Gastrointestinal disorders
    Crohn's disease deterioration
         subjects affected / exposed
    20 / 70 (28.57%)
    12 / 39 (30.77%)
    22 / 71 (30.99%)
    14 / 72 (19.44%)
         occurrences all number
    20
    12
    22
    14
    Abdominal pain
         subjects affected / exposed
    7 / 70 (10.00%)
    1 / 39 (2.56%)
    10 / 71 (14.08%)
    9 / 72 (12.50%)
         occurrences all number
    7
    1
    12
    10
    Nausea
         subjects affected / exposed
    3 / 70 (4.29%)
    2 / 39 (5.13%)
    4 / 71 (5.63%)
    6 / 72 (8.33%)
         occurrences all number
    3
    3
    4
    6
    Flatulence
         subjects affected / exposed
    3 / 70 (4.29%)
    2 / 39 (5.13%)
    3 / 71 (4.23%)
    4 / 72 (5.56%)
         occurrences all number
    3
    2
    3
    4
    Abdominal pain upper
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 39 (0.00%)
    2 / 71 (2.82%)
    7 / 72 (9.72%)
         occurrences all number
    1
    0
    2
    7
    Haematochezia
         subjects affected / exposed
    0 / 70 (0.00%)
    2 / 39 (5.13%)
    1 / 71 (1.41%)
    0 / 72 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 70 (1.43%)
    3 / 39 (7.69%)
    1 / 71 (1.41%)
    0 / 72 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 70 (1.43%)
    2 / 39 (5.13%)
    2 / 71 (2.82%)
    0 / 72 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 70 (4.29%)
    3 / 39 (7.69%)
    4 / 71 (5.63%)
    7 / 72 (9.72%)
         occurrences all number
    3
    3
    6
    7
    Back pain
         subjects affected / exposed
    5 / 70 (7.14%)
    3 / 39 (7.69%)
    5 / 71 (7.04%)
    4 / 72 (5.56%)
         occurrences all number
    5
    3
    5
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 70 (12.86%)
    6 / 39 (15.38%)
    9 / 71 (12.68%)
    10 / 72 (13.89%)
         occurrences all number
    9
    6
    9
    10
    Urinary tract infection
         subjects affected / exposed
    3 / 70 (4.29%)
    1 / 39 (2.56%)
    0 / 71 (0.00%)
    2 / 72 (2.78%)
         occurrences all number
    3
    1
    0
    2

    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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