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    Clinical Trial Results:
    Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis

    Summary
    EudraCT number
    		 2020-001961-34
    Trial protocol
    		 DE   GB   HU   SK   NL   BE   PL   IT  
    Global end of trial date
    03 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2024
    First version publication date
    06 Mar 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RDG-1/PBC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstr. 5, Freiburg im Breisgau, Germany, 79108
    Public contact
    Headquarters, Dr. Falk Pharma GmbH, +49 76115140, zentrale@drfalkpharma.de
    Scientific contact
    Headquarters, 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
    17 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of 3 doses of RhuDex versus (vs) placebo for the treatment of primary biliary cholangitis (PBC) in patients with an inadequate response to ursodeoxycholic acid (UDCA)
    Protection of trial subjects
    Close supervision of subjects by implementing interim visits every 14 days for the first 4 weeks and every 4 weeks up to week 12 and one follow up visit at week 16 to guarantee their safety and wellbeing. 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.
    Background therapy
    		 All patients were to continue their pre-trial dose of UDCA throughout trial participation without changing the dosing regimen
    Evidence for comparator
    		 As all patients will continue standard of care treatment with UDCA, a placebo arm will be included as control due to regulatory recommendations to evaluate dose-related benefits and adverse effects in randomised, double-blind, placebo controlled studies.
    Actual start date of recruitment
    03 Mar 2021
    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: 3
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Slovakia: 3
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Czechia: 20
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    82
    EEA total number of subjects
    75
    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)
    68
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total 82 patients were included in Belgium, Czech republic, Germany, Hungary, Italy, The Netehrlands, Poland, Slovakia, Spain and United Kingdom from March 2021 to May 2023.

    Pre-assignment
    Screening details
    		 A total of 120 patients were screened for the trial, 38 of whom were screening failures. A total of 82 patients were randomized. 79 patients were treated and included in the full 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
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Blinding was achieved by the application of the same amount of granules for each verum dose and placebo to each patient. Placebo granules matched verum granules in size, taste, and appearance; the granules of both verum and placebo were filled in identical sachets.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RhuDex 25 mg twice daily
    Arm description
    		 RhuDex 25 mg twice daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    25 mg RhuDex orally twice daily
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    RhuDex 25 mg twice daily To be taken orally unchewed twice daily in the morning and evening about 30 to 60 minutes before a meal with plenty of water.

    Arm title
    		 RhuDex 50 mg twice daily
    Arm description
    		 RhuDex 50 mg twice daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    50 mg RhuDex orally twice daily
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg RhuDex orally twice daily To be taken orally unchewed twice daily in the morning and evening about 30 to 60 minutes before a meal with plenty of water.

    Arm title
    		 RhuDex 100 mg orally twice daily
    Arm description
    		 RhuDex 100 mg orally twice daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    100 mg RhuDex orally twice daily
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    RhuDex 100 mg twice daily To be taken orally unchewed twice daily in the morning and evening about 30 to 60 minutes before a meal with plenty of water.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for RhuDex orally twice daily
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for RhuDex twice daily To be taken orally unchewed twice daily in the morning and evening about 30 to 60 minutes before a meal with plenty of water.

    Number of subjects in period 1 [1]
    		RhuDex 25 mg twice daily RhuDex 50 mg twice daily RhuDex 100 mg orally twice daily Placebo
    Started
    20
    21
    19
    19
    Completed
    15
    14
    11
    18
    Not completed
    5
    7
    8
    1
         Consent withdrawn by subject
    -
    2
    1
    -
         Adverse event, non-fatal
    3
    1
    5
    -
         violation of inclusion/exclusion criteria
    -
    -
    2
    -
         study terminated by sponsor
    2
    3
    -
    1
         other reason
    -
    1
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 82 patients were randomized. 3 patients have been randomized but not treated. Baseline characteristics are only reported for the 79 patients having received treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Phase (overall trial)
    Reporting group description
    		 82 patients were randomized. 3 patients have been randomized but not treated. Baseline characteristics are only reported for the 79 patients having received treatment.

    Reporting group values
    		 Treatment Phase (overall trial) Total
    Number of subjects
    		 79 79
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 66 66
        From 65-84 years
    		 13 13
    Age continuous
    Units: years
        median (full range (min-max))
    		 56 (37 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 74 74
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    RhuDex 25 mg twice daily
    Reporting group description
    		 RhuDex 25 mg twice daily

    Reporting group title
    RhuDex 50 mg twice daily
    Reporting group description
    		 RhuDex 50 mg twice daily

    Reporting group title
    RhuDex 100 mg orally twice daily
    Reporting group description
    		 RhuDex 100 mg orally twice daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Relative change (%) in alkaline phosphatase from Baseline to end of treatment

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    End point title
    		 Relative change (%) in alkaline phosphatase from Baseline to end of treatment
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks treatment: from Baseline to end of treatment , LOCF (last observation carried forward)
    End point values
    		 RhuDex 25 mg twice daily RhuDex 50 mg twice daily RhuDex 100 mg orally twice daily Placebo
    Number of subjects analysed
    20
    21
    19
    19
    Units: %
        arithmetic mean (confidence interval 95%)
    3.50 (-1.71 to 8.70)
    1.75 (-8.35 to 11.85)
    9.86 (-1.69 to 21.42)
    -1.53 (-8.03 to 4.97)
    Statistical analysis title
    		 Rhudex 25mg twice daily vs Placebo
    Comparison groups
    Placebo v RhuDex 25 mg twice daily
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7884 [1]
    Method
    		 pairwise Wilcoxon rank sum test
    Confidence interval
    Notes
    [1] - P-value from pairwise Wilcoxon rank sum test, one sided
    Statistical analysis title
    		 Rhudex 50mg twice daily vs Placebo
    Comparison groups
    Placebo v RhuDex 50 mg twice daily
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6068 [2]
    Method
    		 pairwise Wilcoxon rank sum test
    Confidence interval
    Notes
    [2] - P-value from pairwise Wilcoxon rank sum test, one sided
    Statistical analysis title
    		 Rhudex 100mg twice daily vs Placebo
    Comparison groups
    Placebo v RhuDex 50 mg twice daily
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9575 [3]
    Method
    		 pairwise Wilcoxon rank sum test
    Confidence interval
    Notes
    [3] - P-value from pairwise Wilcoxon rank sum test, one sided

    Secondary: Partial normalization of serum alkaline phsophatase (ALP)

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    End point title
    		 Partial normalization of serum alkaline phsophatase (ALP)
    End point description
    Partial normalization ALP serum level <1.5 × upper limit of normal at 1 or more scheduled postbaseline visits up to EOT
    End point type
    Secondary
    End point timeframe
    12 weeks treatment: from Baseline to end of treatment , LOCF (last observation carried forward)
    End point values
    		 RhuDex 25 mg twice daily RhuDex 50 mg twice daily RhuDex 100 mg orally twice daily Placebo
    Number of subjects analysed
    20
    21
    19
    19
    Units: Patients
    0
    2
    2
    5
    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 V1 (Baseline visit), V2, V3, V4, V5 (End of Treatment visit) and V6 (Follow-Up Visit) .
    Adverse event reporting additional description
    Treatment emergent adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    RhuDex 25 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    RhuDex 50 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    RhuDex 100 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 RhuDex 25 mg twice daily RhuDex 50 mg twice daily RhuDex 100 mg twice daily Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    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
    Ischaemic stroke
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (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
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 RhuDex 25 mg twice daily RhuDex 50 mg twice daily RhuDex 100 mg twice daily Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 20 (60.00%)
    12 / 21 (57.14%)
    16 / 19 (84.21%)
    10 / 19 (52.63%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Axillary pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Discomfort
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 21 (14.29%)
    3 / 19 (15.79%)
    0 / 19 (0.00%)
         occurrences all number
    1
    3
    3
    0
    Influenza like illness
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    0
    1
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Glutamate dehydrogenase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Weight decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    2
    Headache
         subjects affected / exposed
    4 / 20 (20.00%)
    3 / 21 (14.29%)
    5 / 19 (26.32%)
    2 / 19 (10.53%)
         occurrences all number
    4
    3
    7
    2
    Lethargy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tremor
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear and labyrinth disorders
    Meniere's disease
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Photopsia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    3 / 19 (15.79%)
    1 / 19 (5.26%)
         occurrences all number
    0
    3
    3
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 21 (4.76%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
         occurrences all number
    2
    1
    2
    0
    Diarrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 21 (9.52%)
    5 / 19 (26.32%)
    0 / 19 (0.00%)
         occurrences all number
    1
    2
    5
    0
    Dyspepsia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    3 / 20 (15.00%)
    2 / 21 (9.52%)
    3 / 19 (15.79%)
    2 / 19 (10.53%)
         occurrences all number
    3
    2
    3
    2
    Toothache
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    2 / 19 (10.53%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    2
    3
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 21 (9.52%)
    2 / 19 (10.53%)
    2 / 19 (10.53%)
         occurrences all number
    2
    2
    2
    6
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Back pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Plantar fasciitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscular weakness
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    2
    0
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    4 / 19 (21.05%)
         occurrences all number
    0
    0
    1
    4
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Impaired fasting glucose
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jan 2021
    One global amendment was issued to Clinical Trial Protocol Version 1.0, dated 06-Jul-2020. The new protocol version 2.0, dated 27-Jan-2021, has been made to consolidate and implement all comments of the Competent Authorities and the Ethics Committees.

    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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