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    Clinical Trial Results:
    Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis

    Summary
    EudraCT number
    		 2013-001912-31
    Trial protocol
    		 DE   HU   ES   SE   NL   DK   LT   PT   AT   IT  
    Global end of trial date
    13 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2021
    First version publication date
    14 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BUG-3/MIC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02142634
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstr. 5, Freiburg, Germany, 79108 Freiburg
    Public contact
    Clinical Research and Development, Dr. Falk Pharma GmbH, 49 76115140, zentrale@drfalkpharma.de
    Scientific contact
    Clinical Research and Development, Dr. Falk Pharma GmbH, 49 76115140, 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
    18 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jan 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the trial is to demonstrate efficacy of budesonide for induction of remission in patients with active incomplete microscopic colitis
    Protection of trial subjects
    Close supervision of patients by regular intermin visits, safety and wellbeing guaranteed. Patient documents e.g. ICF - according to Declaration of Helsinki, ICH-GCP, local laws/regulations - submitted to ECs and approved prior to recruiting any patient. Upfront enrollment of a patient he/she a) was well informed about the trial, b) consented to participate in writing, c) and therefore, participation in trial was voluntary. Withdrawal of study always given without fear about loss of medical care. Patient consented to follow the instructions of the protocol/study team.
    Background therapy
    		 none
    Evidence for comparator
    		 Placebo granules
    Actual start date of recruitment
    11 Aug 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Sweden: 7
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Hungary: 25
    Country: Number of subjects enrolled
    Lithuania: 2
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    31
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total 63 patients were screened of which 44 patients were randomized in Germany, Denmark, Hungary, Lithuania, The Netherlands, Spain, Sweden. Recruitment period: January 2014 - June 2019.

    Pre-assignment
    Screening details
    		 Screening Criteria: 1) Informed Consent signed, 2) Age between 18 - 80, 3) incomplete microscopic colitis. In total, 63 patients were screened, thereof, 44 patients were randomized, received at least one dose of study medication and were inculded into the analyses as described below.

    Period 1
    Period 1 title
    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Budesonide 9 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide Granules (Budenofalk 9 mg gastro-resistant granules)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    1 Budesonide sachet once daily in the morning.

    Arm title
    		 Arm B
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Granules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    1 Placebo sachet once daily in the morning.

    Number of subjects in period 1
    		Arm A Arm B
    Started
    21
    23
    Completed
    15
    17
    Not completed
    6
    6
         Consent withdrawn by subject
    2
    2
         Inclusion/exclusion criteria not met
    1
    -
         Adverse event, non-fatal
    1
    1
         Lack of efficacy
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Budesonide 9 mg

    Reporting group title
    Arm B
    Reporting group description
    		 Placebo

    Reporting group values
    		 Arm A Arm B Total
    Number of subjects
    		 21 23 44
    Age categorical
    44 patients were randomized into the trial aged between the age groups ≥ 18 to ≤ 64 years and > 64 to ≤ 80 years
    Units: Subjects
        Adults (18-64 years)
    		 11 20 31
        From 65-84 years
    		 10 3 13
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.2 ( 18.97 ) 46.5 ( 15.51 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 14 30
        Male
    		 5 9 14
    Subject analysis sets

    Subject analysis set title
    Safety Analyse Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set (SAF) includes all randomised patients (as treated) who were treated at least one time with the IMP.

    Subject analysis set title
    Intention-to-treat (ITT) Analysis Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The full analysis set (FAS) includes all randomised patients (as randomised) who received at least one dose of the IMP.

    Subject analysis set title
    Per-protocol (PP) Analysis Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) set includes all patients of the FAS, if e.g. all of the major inclusion criteria, none of the major exclusion criteria fulfilled.

    Subject analysis sets values
    		 Safety Analyse Set Intention-to-treat (ITT) Analysis Set Per-protocol (PP) Analysis Set
    Number of subjects
    44
    44
    28
    Age categorical
    44 patients were randomized into the trial aged between the age groups ≥ 18 to ≤ 64 years and > 64 to ≤ 80 years
    Units: Subjects
        Adults (18-64 years)
    31
    31
        From 65-84 years
    13
    13
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49.2 ( 17.28 )
    49.2 ( 17.28 )
    ( )
    Gender categorical
    Units: Subjects
        Female
    30
    30
        Male
    14
    14

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Budesonide 9 mg

    Reporting group title
    Arm B
    Reporting group description
    		 Placebo

    Subject analysis set title
    Safety Analyse Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set (SAF) includes all randomised patients (as treated) who were treated at least one time with the IMP.

    Subject analysis set title
    Intention-to-treat (ITT) Analysis Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The full analysis set (FAS) includes all randomised patients (as randomised) who received at least one dose of the IMP.

    Subject analysis set title
    Per-protocol (PP) Analysis Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) set includes all patients of the FAS, if e.g. all of the major inclusion criteria, none of the major exclusion criteria fulfilled.

    Primary: Clinical Remission

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    End point title
    		 Clinical Remission
    End point description
    mean of < 3 stools/day and a mean of < 1 watery stool/day
    End point type
    Primary
    End point timeframe
    After 8 weeks of treatment with study medication starting with Baseline.
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    21
    23
    Units: numbers of patients
        number (confidence interval 95%)
    71.4 (47.8 to 88.7)
    43.5 (23.2 to 65.5)
    Statistical analysis title
    		 Full analysis set (FAS)
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0582
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Median time to Clinical Remission

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    End point title
    		 Median time to Clinical Remission
    End point description
    End point type
    Secondary
    End point timeframe
    Within 8 weeks starting with Baseline/randomisation to Final Visit (week 8).
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    21
    23
    Units: days
        median (confidence interval 95%)
    7 (7 to 21)
    33 (7 to 1000)
    Statistical analysis title
    		 Full analysis set (FAS)
    Comparison groups
    Arm B v Arm A
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0915
    Method
    		 Logrank
    Confidence interval

    Secondary: Mean number of watery stools

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    End point title
    		 Mean number of watery stools
    End point description
    Mean change from Baseline/randomisation to Final Visit/LOCF
    End point type
    Secondary
    End point timeframe
    Within 8 weeks starting with Baseline/randomisation to Final Visit (week 8).
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    21
    23
    Units: Number of watery stools
        arithmetic mean (confidence interval 95%)
    -12.5 (-17.83 to -7.22)
    -5.4 (-10.69 to -0.03)
    Statistical analysis title
    		 Full analysis set (FAS)
    Statistical analysis description
    Mean difference (Budesonide - Placebo)
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    44
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.0542
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were assessed at all interim visits and at the Final Visit, thus every 2 weeks.
    Adverse event reporting additional description
    Treatment emergent adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 1 sachet Budesonide granules

    Reporting group title
    Arm B
    Reporting group description
    		 1 Sachet Placebo granules

    Serious adverse events
    		 Arm A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 21 (42.86%)
    8 / 23 (34.78%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Migraine
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Abdominal distension
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Haematochezia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Infections and infestations
    Gingivitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Skin infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 May 2016
    a) clarification of exclusion criterion regarding bowel resections, b) clarification of exclusion criterion regarding celiac disease, c) consideration of bismuth and probiotics for exclusion criteria and forbidden concomitant medication, d)inclusion of an optional pregnancy test at baseline and e) administrative changes.

    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.
    Small numbers of subjects analysed. Low recruitment rate.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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