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    Clinical Trial Results:
    Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis

    Summary
    EudraCT number
    2014-005635-14
    Trial protocol
    DE   LV   HU   LT  
    Global end of trial date
    20 Feb 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Oct 2018
    First version publication date
    11 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BUX-3/UCA
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02550418
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dr. Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstrasse 5, Freiburg, Germany, 79288
    Public contact
    Clinical Research and Development, Dr. Falk Pharma GmbH, 0049 7611514-0, zentrale@drfalkpharma.de
    Scientific contact
    Clinical Research and Development, 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
    22 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the efficacy of a 8-week treatment with once-daily 9 mg budesonide in patients with active ulcerative 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 to 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
    13 Oct 2015
    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
    Germany: 4
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Latvia: 37
    Country: Number of subjects enrolled
    Lithuania: 13
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    56
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    In total 61 patients from Germany, Hungary, Lithuania and Latvia were enrolled and treated.

    Pre-assignment
    Screening details
    Patients signing the informed consent form were screened for 7 to 10 days to evaluate eligibility for the study. A total of 66 patients was screened for enrolment into the study. Five patients could not be included into the treatment phase. The most frequent reason for screening failure was violation of eligibility criteria.

    Period 1
    Period 1 title
    8-week open-label treatment phase (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    Open-label treatment with budesonide
    Arm description
    8-week treatment with one budesonide 9 mg capsule, hard (BUX-PV) once-daily. Analysis set: Full Analysis Set, which was defined according to the intention-to-treat principle and included all patients who received at least one dose of the investigational medicinal product.
    Arm type
    Experimental

    Investigational medicinal product name
    Budesonide 9 mg capsule, hard (BUX-PV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    One budesonide 9 mg capsule, hard (BUX-PV) once-daily in the morning.

    Number of subjects in period 1
    Open-label treatment with budesonide
    Started
    61
    Completed
    49
    Not completed
    12
         Lack of patient's co-operation
    1
         Lack of efficacy
    9
         Adverse event, non-fatal
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-label treatment with budesonide
    Reporting group description
    8-week treatment with one budesonide 9 mg capsule, hard (BUX-PV) once-daily. Analysis set: Full Analysis Set, which was defined according to the intention-to-treat principle and included all patients who received at least one dose of the investigational medicinal product.

    Reporting group values
    Open-label treatment with budesonide Total
    Number of subjects
    61 61
    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)
    56 56
        From 65-84 years
    5 5
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.2 ± 14.5 -
    Gender categorical
    Units: Subjects
        Female
    29 29
        Male
    32 32

    End points

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    End points reporting groups
    Reporting group title
    Open-label treatment with budesonide
    Reporting group description
    8-week treatment with one budesonide 9 mg capsule, hard (BUX-PV) once-daily. Analysis set: Full Analysis Set, which was defined according to the intention-to-treat principle and included all patients who received at least one dose of the investigational medicinal product.

    Primary: Clinical remission at week 8 / EOT

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    End point title
    Clinical remission at week 8 / EOT [1]
    End point description
    Percentage of patients being in clinical remission at week 8 / EOT. Clinical remission was defined as Clinical Activity Index (CAI) total score ≤ 4, with subscores 1 and 2 of 0 at week 8 / EOT.
    End point type
    Primary
    End point timeframe
    After 8-week treatment: week 8 / EOT
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Open-label treatment with budesonide
    Number of subjects analysed
    61
    Units: subjects
    29
    No statistical analyses for this end point

    Secondary: Clinical and endoscopic remission at week 8 / EOT

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    End point title
    Clinical and endoscopic remission at week 8 / EOT
    End point description
    The proportion of patients being in combined clinical and endoscopic remission at week 8 / EOT. Combined clinical and endoscopic remission was defined as modified Disease Activity Index (mDAI) stool frequency subscore = 0, rectal bleeding subscore = 0, mucosal appearance subscore = 0 or 1 and physician's rating of disease activity subscore = 0 or 1 at week 8 / EOT.
    End point type
    Secondary
    End point timeframe
    After 8-week treatment: week 8 / EOT
    End point values
    Open-label treatment with budesonide
    Number of subjects analysed
    61
    Units: Subjects
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to week 8 / EOT
    Adverse event reporting additional description
    All adverse events which occurred from the first drug administration to week 8 / EOT.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Open-label treatment with budesonide
    Reporting group description
    8-week treatment with one budesonide 9 mg capsule, hard (BUX-PV) once-daily. Analysis set: The Safety Analysis Set included all patients who received at least one dose of the investigational medicinal product and had at least one follow-up value for the safety variables to be analysed. If the administration of any investigational medicinal product was not certain, the patient was included in the Safety Analysis Set.

    Serious adverse events
    Open-label treatment with budesonide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 61 (1.64%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Open-label treatment with budesonide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 61 (37.70%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Post-traumatic pain
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Eosinophil count increased
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Lipase increased
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Eosinophilia
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    4
    Migraine
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    2
    Syncope
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    7 / 61 (11.48%)
         occurrences all number
    7
    Constipation
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Large intestine polyp
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Oral mucosal erythema
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Rectal tenesmus
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erythema nodosum
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Infections and infestations
    Herpes simplex
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1

    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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