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    Clinical Trial Results:
    Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis

    Summary
    EudraCT number
    		 2008-005994-36
    Trial protocol
    		 DE   HU   SE   BE   DK   CZ   LT   ES   NL   IT  
    Global end of trial date
    16 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Mar 2018
    First version publication date
    30 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BUG-1/LMC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01209208
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstrasse 5, Freiburg, Germany, 79288
    Public contact
    Department of Clinical Research, Dr. Falk Pharma GmbH, 0049 7611514-0, zentrale@drfalkpharma.de
    Scientific contact
    Department of Clinical Research, Dr. Falk Pharma GmbH, 0049 7611514-0, zentrale@drfalkpharma.de
    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
    01 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial is to evaluate the efficacy of 9 mg budesonide/day and 3 g mesalazine/day compared to placebo for the induction of remission in lymphocytic colitis.
    Protection of trial subjects
    Close supervision of subjects by implementing interim visits every 14 days to guarantee their safety and wellbeing. Prior to recruitment of patients, all relevant documents of the clinical study were submitted and proved 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.
    Background therapy
    		 None
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    06 May 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
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Sweden: 15
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Lithuania: 4
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    35
    From 65 to 84 years
    21
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total 57 patients were randomized from Germany, Sweden, Denmark, Hungary, Lithuania, Spain, Czech Republic and the Netherlands.

    Pre-assignment
    Screening details
    		 Patients signing the informed consent form were screened for up to 2 weeks to evaluate eligibility for the study. A total of 105 patients was screened for enrolment into the study. Forty-eight patients could not be randomised. The most frequent reason for screening failure was violation of eligibility criteria.

    Period 1
    Period 1 title
    8-week double-blind treatment phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    The study was to be conducted using the double-dummy technique to guarantee the double-blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment A
    Arm description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg granules and 2x sachets Salofalk® 1.5g placebo granules
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budenofalk® 9 mg granules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant granules
    Routes of administration
    Oral use
    Dosage and administration details
    One sachet Budenofalk® 9 mg granules once daily in the morning

    Investigational medicinal product name
    Salofalk® 1.5g placebo granules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant granules
    Routes of administration
    Oral use
    Dosage and administration details
    Two sachets Salofalk® 1.5g placebo granules once daily in the morning

    Arm title
    		 Treatment B
    Arm description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg placebo granules and 2x sachets Salofalk® 1.5g granules
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budenofalk® 9 mg placebo granules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant granules
    Routes of administration
    Oral use
    Dosage and administration details
    One sachet Budenofalk® 9 mg placebo granules once daily in the morning.

    Investigational medicinal product name
    Salofalk® 1.5g granules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant granules
    Routes of administration
    Oral use
    Dosage and administration details
    Two sachets Salofalk® 1.5g granules once daily in the morning.

    Arm title
    		 Treatment C
    Arm description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg placebo granules and 2x sachets Salofalk® 1.5g placebo granules
    Arm type
    		 Placebo

    Investigational medicinal product name
    Budenofalk® 9 mg placebo granules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant granules
    Routes of administration
    Oral use
    Dosage and administration details
    One sachet Budenofalk® 9 mg placebo granules once dail in the morning

    Investigational medicinal product name
    Salofalk® 1.5g placebo granules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant granules
    Routes of administration
    Oral use
    Dosage and administration details
    Two sachets Salofalk® 1.5g placebo granules once daily in the morning

    Number of subjects in period 1
    		Treatment A Treatment B Treatment C
    Started
    19
    19
    19
    Completed
    15
    15
    14
    Not completed
    4
    4
    5
         Adverse event, non-fatal
    2
    3
    -
         Other reasons
    1
    -
    -
         Lack of patient's co-operation
    1
    1
    -
         Lack of efficacy
    -
    -
    5
    Period 2
    Period 2 title
    4-week open-label treatment phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 Open-label treatment
    Arm description
    		 4-week open-label (OL) treatment phase with 1x sachet Budenofalk® 9 mg granules, once daily, for patients who were • prematurely withdrawn from the double-blind treatment phase due to lack of efficacy, • not in clinical remission at the end of the double-blind treatment phase or • experiencing a clinical relapse during the follow-up phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budenofalk® 9 mg granules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant granules
    Routes of administration
    Oral use
    Dosage and administration details
    One sachet Budenofalk® 9 mg granules once daily in the morning

    Number of subjects in period 2 [1]
    		Open-label treatment
    Started
    19
    Completed
    17
    Not completed
    2
         Adverse event, non-fatal
    1
         Lack of patient's co-operation
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The 4-week open-label treatment phase could only be entered by a subset of patients of the preceding period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg granules and 2x sachets Salofalk® 1.5g placebo granules

    Reporting group title
    Treatment B
    Reporting group description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg placebo granules and 2x sachets Salofalk® 1.5g granules

    Reporting group title
    Treatment C
    Reporting group description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg placebo granules and 2x sachets Salofalk® 1.5g placebo granules

    Reporting group values
    		 Treatment A Treatment B Treatment C Total
    Number of subjects
    		 19 19 19 57
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 11 10 14 35
        From 65-84 years
    		 8 9 4 21
        85 years and over
    		 0 0 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.8 ( 11.5 ) 57.4 ( 18.5 ) 59.0 ( 12.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 14 12 41
        Male
    		 4 5 7 16
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The full analysis set (FAS) defined according to the intention-to-treat principle includes all randomised patients (as randomised) who received at least one dose of the investigational medicinal product.

    Subject analysis set title
    OL analysis set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The open-label (OL) analysis set includes all patients of the FAS who entered the open-label phase and • received at least one dose of the investigational medicinal product during the open-label phase and • have at least one evaluable assessment of efficacy or safety data during the open-label phase.

    Subject analysis sets values
    		 FAS OL analysis set
    Number of subjects
    57
    19
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    35
    12
        From 65-84 years
    21
    6
        85 years and over
    1
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59.1 ( 14.4 )
    60.0 ( 13.8 )
    Gender categorical
    Units: Subjects
        Female
    41
    11
        Male
    16
    8

    End points

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    End points reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg granules and 2x sachets Salofalk® 1.5g placebo granules

    Reporting group title
    Treatment B
    Reporting group description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg placebo granules and 2x sachets Salofalk® 1.5g granules

    Reporting group title
    Treatment C
    Reporting group description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg placebo granules and 2x sachets Salofalk® 1.5g placebo granules
    Reporting group title
    Open-label treatment
    Reporting group description
    		 4-week open-label (OL) treatment phase with 1x sachet Budenofalk® 9 mg granules, once daily, for patients who were • prematurely withdrawn from the double-blind treatment phase due to lack of efficacy, • not in clinical remission at the end of the double-blind treatment phase or • experiencing a clinical relapse during the follow-up phase.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The full analysis set (FAS) defined according to the intention-to-treat principle includes all randomised patients (as randomised) who received at least one dose of the investigational medicinal product.

    Subject analysis set title
    OL analysis set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The open-label (OL) analysis set includes all patients of the FAS who entered the open-label phase and • received at least one dose of the investigational medicinal product during the open-label phase and • have at least one evaluable assessment of efficacy or safety data during the open-label phase.

    Primary: Clinical remission at week 8 / EOT

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    End point title
    		 Clinical remission at week 8 / EOT
    End point description
    Percentage of patients being in clinical remission at week 8 / EOT. Clinical remission was defined as a maximum of 21 stools, thereof not more than 6 watery stools in the last 7 days prior to the week 8 / EOT.
    End point type
    Primary
    End point timeframe
    After 8-week treatment: week 8 / EOT
    End point values
    		 Treatment A Treatment B Treatment C FAS
    Number of subjects analysed
    19
    19
    19
    57
    Units: patients
    15
    12
    8
    35
    Statistical analysis title
    		 Confirmative analysis I
    Statistical analysis description
    Confirmative comparison between Treatment A (Budenofalk® granules) and Treatment C (placebo).
    Comparison groups
    Treatment A v Treatment C
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0101 [2]
    Method
    		 Normal approximation test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.368
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.031
         upper limit
    		 0.633
    Notes
    [1] - Superiority is shown if the lower bound of the 95% repeated confidence interval for the treatment difference with respect to clinical remission is > 0. This corresponds to a local significance level of 0.0164 for the interim analysis / final analysis (incl. overrunning patients).
    [2] - As the p-value is lower than the local significance level of 0.0164 for the interim analysis / final analysis (incl. overrunning patients), superiority has been proven.
    Statistical analysis title
    		 Confirmative analysis II
    Statistical analysis description
    Confirmative comparison between Treatment B (Salofalk® granules) and Treatment C (placebo).
    Comparison groups
    Treatment B v Treatment C
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.0969
    Method
    		 Normal approximation test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.211
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.132
         upper limit
    		 0.508
    Notes
    [3] - Superiority is shown if the lower bound of the 95% repeated confidence interval for the treatment difference with respect to clinical remission is > 0. This corresponds to a local significance level of 0.0164 for the interim analysis / final analysis (incl. overrunning patients).

    Secondary: Histological remission at week 8 / EOT

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    End point title
    		 Histological remission at week 8 / EOT
    End point description
    Percentage of patients beeing in histological remission at week 8 / EOT. Histological remission was defined as ≤ 20 intraepithelial lymphocytes (IELs)/100 epithelial cells.
    End point type
    Secondary
    End point timeframe
    After 8-week treatment: week 8 / EOT
    End point values
    		 Treatment A Treatment B Treatment C FAS
    Number of subjects analysed
    19
    19
    19
    57
    Units: patients
    13
    5
    4
    22
    Statistical analysis title
    		 Explorative analysis I
    Statistical analysis description
    Explorative comparison between Treatment A (Budenfalk® granules) and Treatment C (placebo).
    Comparison groups
    Treatment A v Treatment C
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0081
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Explorative Analysis II
    Statistical analysis description
    Explorative comparison between Treatment B (Salofalk® granules) and Treatment C (placebo)
    Comparison groups
    Treatment B v Treatment C
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Clinical remission at end of OL phase

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    End point title
    		 Clinical remission at end of OL phase
    End point description
    The proportion of patients with clinical remission, defined as a maximum of 21 stools, thereof not more than 6 watery stools in the last 7 days prior to the end of the open-label phase.
    End point type
    Secondary
    End point timeframe
    After 4-week open-label treatment
    End point values
    		 Open-label treatment OL analysis set
    Number of subjects analysed
    17
    17
    Units: patients
    15
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatments A, B, C: from baseline to week 8 / EOT Open-label treatment: from start of open-label treatment phase to week 4 / EOT
    Adverse event reporting additional description
    Treatments A, B, C: all adverse events which occurred from the first drug administration to week 8 / EOT. Open-label treatment: all adverse events which occurred from the first drug administration of open-label treatment to week 4 / EOT.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg granules and 2x sachets Salofalk® 1.5 g placebo granules once daily.

    Reporting group title
    Treatment B
    Reporting group description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg placebo granules and 2x sachets Salofalk® 1.5 g granules once daily.

    Reporting group title
    Treatment C
    Reporting group description
    		 8-week treatment with 1x sachet Budenofalk® 9 mg placebo granules and 2x sachets Salofalk® 1.5g placebo granules once daily.

    Reporting group title
    Open-label treatment
    Reporting group description
    		 4-week open-label treatment with 1x sachet Budenofalk® 9 mg granules once daily.

    Serious adverse events
    		 Treatment A Treatment B Treatment C Open-label treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 19 (10.53%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (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
    Pancreatitis acute
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (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
    Musculoskeletal and connective tissue disorders
    Metatarsalgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (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: 0%
    Non-serious adverse events
    		 Treatment A Treatment B Treatment C Open-label treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 19 (42.11%)
    13 / 19 (68.42%)
    7 / 19 (36.84%)
    5 / 19 (26.32%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood urea increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Weight increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Headache
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    1
    7
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Colitis microscopic
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Vomiting
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Night sweats
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Rash
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sleep disorder
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Haemarthrosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tendon pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Furuncle
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Pneumonia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperphagia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jan 2010
    Primary reason for amendment no. 1 was that lymphocytic colitis may be associated with the use of certain drugs. A high level of likelihood of being able to cause microscopic colitis is attributed to acarbose, aspirin, Cyclo3Fort, lansoprazole, nonsteroidal anti-inflammatory drugs, ranitidine, sertraline, and ticlopidine. Therefore, the previous and concomitant medication section has been amended.
    10 Jun 2013
    Amendment 2 was required to take into account the new information of the latest Investigator's Brochure for Salofalk® (oral formulations). Some administrative additions were also included in the protocol to verbalize more detailed guidance as per the current status quo.
    30 Sep 2015
    Amendment no. 3 which was requested by the Italian competent authority, agenzia italiana del farmaco (AIFA), was applicable only for Italy and only submitted to the IECs of Italy. It focused on live vaccination and diagnosis of chickenpox, herpes zoster or measles. Additional exclusion and withdrawal criteria were included.
    22 Jun 2016
    Amendment no. 4 referred to the fact that the planned interim analysis was to be performed after inclusion of 54 patients who were evaluable in the intention-to-treat analysis (approximately 18 patients in each treatment group), instead of 60 patients.
    16 Aug 2016
    Substantial amendment no. 5 was submitted to the IECs of Germany, Hungary, Spain and Lithuania and referred to basic clarifications of the study protocol.

    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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