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    Clinical Trial Results:
    Randomized, double-blind, multicentre study to compare the efficacy and safety of two different dosages of a novel budesonide suppository versus a mesalazine suppository versus a combination therapy of budesonide/mesalazine suppositories in patients with acute ulcerative proctitis

    Summary
    EudraCT number
    		 2012-003362-41
    Trial protocol
    		 DE  
    Global end of trial date
    29 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jan 2017
    First version publication date
    07 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BUS-2/UCA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01966783
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstrasse 5, Freiburg, Germany, D-79108
    Public contact
    Department of Clinical Research, Dr. Falk Pharma GmbH, 49 761 1514-0, zentrale@drfalkpharma.de
    Scientific contact
    Department of Clinical Research, Dr. Falk Pharma GmbH, 49 761 1514-0, 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
    13 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this trial are to evaluate the efficacy of two doses of a novel budesonide suppository vs. standard treatment with mesalazine suppository and to evaluate the efficacy of a combined treatment of novel budesonide suppository with standard mesalazine suppository vs. standard mesalazine suppository in patients with acute ulcerative proctitis.
    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
    		 Mesalazine 1 g suppository is registered for the treatment of acute mild to moderate ulcerative colitis that is limited to the rectum (ulcerative proctitis).
    Actual start date of recruitment
    11 Nov 2013
    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
    Russian Federation: 155
    Country: Number of subjects enrolled
    Germany: 55
    Country: Number of subjects enrolled
    Ukraine: 127
    Worldwide total number of subjects
    337
    EEA total number of subjects
    55
    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)
    324
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total 337 patients were included in Germany, Russia and Ukraine from November 2013 to July 2015.

    Pre-assignment
    Screening details
    		 Screening Criteria: 1. Signed Informed Consent 2. Aged 18 to 75 years 3. Active ulcerative proctitis In total, 343 patients were screened. Thereof 337 patients were randomised, received at least one dose of study medication and were included in the safety set and intention-to-treat (ITT) analysis set.

    Period 1
    Period 1 title
    Treatment Phase (overall trial) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Assessor, Subject
    Blinding implementation details
    Conducted with double-dummy technique to guarantee double-blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 One budesonide 2 mg suppository in the morning. One mesalazine placebo suppository at bedtime.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide 2 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    One budesonide 2 mg suppository in the morning.

    Investigational medicinal product name
    Mesalazine placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    One mesalazine placebo suppository at bedtime.

    Arm title
    		 Arm B
    Arm description
    		 One budesonide 4 mg suppository in the morning. One mesalazine placebo suppository at bedtime.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide 4mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    One budesonide 4 mg suppository in the morning.

    Investigational medicinal product name
    Mesalazine placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    One mesalazine placebo suppository at bedtime.

    Arm title
    		 Arm C
    Arm description
    		 One budesonide placebo suppository in the morning. One mesalazine 1 g suppository at bedtime.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mesalazine 1 g
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    One mesalazine 1 g suppository at bedtime.

    Investigational medicinal product name
    Budesonide placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    One budesonide placebo suppository in the morning.

    Arm title
    		 Arm D
    Arm description
    		 One budesonide 2 mg suppository in the morning. One mesalazine 1 g suppository at bedtime.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide 2 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    One budesonide 2 mg suppository in the morning.

    Investigational medicinal product name
    Mesalazine 1 g
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    One mesalazine 1 g suppository at bedtime

    Number of subjects in period 1
    		Arm A Arm B Arm C Arm D
    Started
    89
    79
    81
    88
    Completed
    80
    71
    77
    82
    Not completed
    9
    8
    4
    6
         Adverse event, non-fatal
    1
    -
    1
    1
         Lack of patient's co-operation
    4
    1
    1
    1
         Lack of efficacy
    1
    3
    -
    1
         Protocol deviation
    3
    4
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Phase (overall trial)
    Reporting group description
    		 343 patients have signed an Informed Consent at Screening. 337 patients were finally randomised in one of the four treatment groups. 6 patients were Screening failures.

    Reporting group values
    		 Treatment Phase (overall trial) Total
    Number of subjects
    		 337 337
    Age categorical
    337 Patients were randomized into the trial aged 20 to 77 years.
    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)
    		 324 324
        From 65-84 years
    		 13 13
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.6 ± 12.8 -
    Gender categorical
    Subjects of both sex were recruited in this trial.
    Units: Subjects
        Female
    		 195 195
        Male
    		 142 142

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 One budesonide 2 mg suppository in the morning. One mesalazine placebo suppository at bedtime.

    Reporting group title
    Arm B
    Reporting group description
    		 One budesonide 4 mg suppository in the morning. One mesalazine placebo suppository at bedtime.

    Reporting group title
    Arm C
    Reporting group description
    		 One budesonide placebo suppository in the morning. One mesalazine 1 g suppository at bedtime.

    Reporting group title
    Arm D
    Reporting group description
    		 One budesonide 2 mg suppository in the morning. One mesalazine 1 g suppository at bedtime.

    Primary: Time to resolution of clinical symptoms

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    End point title
    		 Time to resolution of clinical symptoms
    End point description
    Time to resolution of clinical symptoms (defined as the first day of 3 consecutive days with a score of 0 for “rectal bleeding” and “stool frequency”). Analysed by descriptive statistics using the Kaplan-Meier estimator, 50% percentile estimates [days].
    End point type
    Primary
    End point timeframe
    Within 8 weeks starting with Baseline/randomisation to Final Visit (week 8).
    End point values
    		 Arm A Arm B Arm C Arm D
    Number of subjects analysed
    89
    79
    81
    88
    Units: days
        Time to resolution of clinical symptoms
    39
    30
    26
    32
    Statistical analysis title
    		 Explorative analysis
    Statistical analysis description
    Pairwise comparison between treatment groups was performed using the log-rank test.
    Comparison groups
    Arm C v Arm A
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.041
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - Log-rank test
    Statistical analysis title
    		 Explorative analysis
    Statistical analysis description
    Pairwise comparison between treatment groups was performed using the log-rank test.
    Comparison groups
    Arm C v Arm B
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.431
    Method
    		 Logrank
    Confidence interval
    Notes
    [2] - Log-rank test
    Statistical analysis title
    		 Explorative analysis
    Statistical analysis description
    Pairwise comparison between treatment groups was performed using the log-rank test.
    Comparison groups
    Arm C v Arm D
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.858
    Method
    		 Logrank
    Confidence interval
    Notes
    [3] - Log-rank test
    Statistical analysis title
    		 Explorative analysis
    Statistical analysis description
    Pairwise comparison between treatment groups was performed using the log-rank test.
    Comparison groups
    Arm D v Arm A
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.031
    Method
    		 Logrank
    Confidence interval
    Notes
    [4] - Log-rank test
    Statistical analysis title
    		 Explorative analysis
    Statistical analysis description
    Pairwise comparison between treatment groups was performed using the log-rank test.
    Comparison groups
    Arm D v Arm B
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.343
    Method
    		 Logrank
    Confidence interval
    Notes
    [5] - Log-rank test
    Statistical analysis title
    		 Explorative analysis
    Statistical analysis description
    Pairwise comparison between treatment groups was performed using the log-rank test.
    Comparison groups
    Arm B v Arm A
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.191
    Method
    		 Logrank
    Confidence interval
    Notes
    [6] - Log-rank test

    Secondary: Clinical and endoscopic remission

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    End point title
    		 Clinical and endoscopic remission
    End point description
    Clinical and endoscopic remission at the final/withdrawal visit was defined as: total modified UC-DAI ≤ 1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and at least a 1-point reduction in the subscore for mucosal appearance at the final/withdrawal visit.
    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 Arm C Arm D
    Number of subjects analysed
    89
    79
    81
    88
    Units: Patients
    29
    35
    41
    39
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were assessed at all interim visits (Day 14, day 28, day 42 and at the Final Visit (Day56), 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
    16.0
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 1 Budesonide 2 mg suppository in the morning 1 Mesalazine placebo suppository at bedtime

    Reporting group title
    Arm B
    Reporting group description
    		 1 Budesonide 4 mg suppository in the morning 1 Mesalazine placebo suppository at bedtime

    Reporting group title
    Arm C
    Reporting group description
    		 1 Budesonide placebo suppository in the morning 1 Mesalazine 1 g suppository at bedtime

    Reporting group title
    Arm D
    Reporting group description
    		 1 Budesonide 2 mg suppository in the morning 1 Mesalazine 1 g suppository at bedtime

    Serious adverse events
    		 Arm A Arm B Arm C Arm D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
    0 / 88 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Arm A Arm B Arm C Arm D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 89 (30.34%)
    25 / 79 (31.65%)
    20 / 81 (24.69%)
    24 / 88 (27.27%)
    Investigations
    Blood cortisol decreased
         subjects affected / exposed
    3 / 89 (3.37%)
    6 / 79 (7.59%)
    1 / 81 (1.23%)
    1 / 88 (1.14%)
         occurrences all number
    3
    7
    1
    1
    Lipase increased
         subjects affected / exposed
    3 / 89 (3.37%)
    1 / 79 (1.27%)
    1 / 81 (1.23%)
    2 / 88 (2.27%)
         occurrences all number
    3
    1
    2
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 89 (6.74%)
    2 / 79 (2.53%)
    4 / 81 (4.94%)
    4 / 88 (4.55%)
         occurrences all number
    10
    2
    5
    8
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 89 (0.00%)
    3 / 79 (3.80%)
    0 / 81 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 89 (5.62%)
    2 / 79 (2.53%)
    2 / 81 (2.47%)
    3 / 88 (3.41%)
         occurrences all number
    5
    2
    2
    4

    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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    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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