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    Clinical Trial Results:
    A Multicenter, Open-label, Safety and Tolerability Extension Trial of 5 mg and 10 mg Elobixibat Daily in the Treatment of Chronic Idiopathic Constipation

    Summary
    EudraCT number
    2012-005601-46
    Trial protocol
    BE   SE   SK   HU   CZ   GB   PL  
    Global end of trial date
    13 May 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    26 May 2016
    First version publication date
    26 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    000081
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01895543
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ferring International Pharmascience Center US, Inc.
    Sponsor organisation address
    100 Interpace Parkway, Parsippany, NJ, United States, 07054
    Public contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    Scientific contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    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
    04 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC)
    Protection of trial subjects
    Before obtaining the consent from patients, the Investigator appropriately explained the aims, methods, anticipated benefits, potential hazards, and any other aspects of the trial which are relevant to the patient’s decision to participate, in a language understood by the patient. The Investigator explained to the patients about their right of freedom to refuse to enter the trial or to withdraw from it at any time, without any consequences on their further care and without the need to justify their decision. The trial was conducted in accordance with the Declaration of Helsinki and in compliance with the International Conference on Harmonization-Good Clinical Practice guidelines.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Sep 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
    Slovakia: 12
    Country: Number of subjects enrolled
    South Africa: 30
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    United Kingdom: 38
    Country: Number of subjects enrolled
    United States: 250
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Canada: 17
    Country: Number of subjects enrolled
    Czech Republic: 10
    Country: Number of subjects enrolled
    Hungary: 34
    Country: Number of subjects enrolled
    Poland: 10
    Worldwide total number of subjects
    411
    EEA total number of subjects
    114
    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)
    362
    From 65 to 84 years
    49
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial enrolled patients from two lead-in, double-blind efficacy trials (000079 and 000080).

    Pre-assignment
    Screening details
    Enrolled patient (with CIC) completed at least 12 weeks of double-blind treatment in either of the lead-in efficacy trials (Trial codes 000079 or 000080). The patients agreed to refrain from making any new, major life-style changes that may affect CIC symptoms from the time of signing the informed consent form through to the last trial visit.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    EBX10
    Arm description
    Elobixibat 10 mg Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.
    Arm type
    Experimental

    Investigational medicinal product name
    Elobixibat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.

    Number of subjects in period 1
    EBX10
    Started
    411
    Completed
    282
    Not completed
    129
         Protocol deviation
    1
         Physician decision
    2
         Subject's substantial non-compliance
    6
         Adverse event, non-fatal
    28
         Consent withdrawn by subject
    43
         Other (Not fulfilling above criteria)
    24
         Lost to follow-up
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EBX10
    Reporting group description
    Elobixibat 10 mg Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.

    Reporting group values
    EBX10 Total
    Number of subjects
    411 411
    Age Categorical
    Units: participants
        <=18 years
    0 0
        Between 18 and 65 years
    362 362
        >=65 years
    49 49
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    48.6 ± 14.13 -
    Gender, Male/Female
    Units: participants
        Female
    351 351
        Male
    60 60
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    2 2
        Asian
    10 10
        Native Hawaiian or Other Pacific Islander
    0 0
        Black or African American
    74 74
        White
    324 324
        More than one race
    1 1
        Unknown or Not Reported
    0 0
    Height
    Units: Meters (m)
        arithmetic mean (standard deviation)
    1.654 ± 0.0834 -
    Weight
    Units: Kilogram (Kg)
        arithmetic mean (standard deviation)
    73.61 ± 14.159 -
    Body Mass Index (BMI)
    Units: Kg/m^2
        arithmetic mean (standard deviation)
    26.87 ± 4.284 -

    End points

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    End points reporting groups
    Reporting group title
    EBX10
    Reporting group description
    Elobixibat 10 mg Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.

    Subject analysis set title
    Per Protocol Analysis Set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Set included all enrolled patients who had no major protocol deviations and included 380 patients.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Set included all enrolled patients who took at least one dose of Investigational Medicinal Product (IMP) and included 409 patients.

    Primary: Number of patients with adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    Number of patients with adverse events (AEs) and serious adverse events (SAEs) [1]
    End point description
    The Investigator recorded all AEs throughout the trial from the time of obtaining informed consent till the last visit (i.e., Visit 6). Information on AE was collected and recorded at each visit. The data are presented for the Safety Analysis Set.
    End point type
    Primary
    End point timeframe
    For the overall 52-week Treatment Period
    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: The data were presented using descriptive statistics. No statistical analysis was performed.
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Number of patients
        AEs
    241
        SAEs
    14
    No statistical analyses for this end point

    Primary: Incidence of markedly abnormal changes in clinical safety laboratory variables

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    End point title
    Incidence of markedly abnormal changes in clinical safety laboratory variables [2]
    End point description
    Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry. The data are presented for the Safety Analysis Set.
    End point type
    Primary
    End point timeframe
    For the overall 52-week Treatment Period
    Notes
    [2] - 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: The data were presented using descriptive statistics. No statistical analysis was performed.
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Number of patients
        Gamma Glutamyl Transferase (Units/Litre): >3*ULN
    6
        Triglycerides : >3.39 millimoles/Litre
    5
        LDL Cholesterol : >4.1 millimoles/Litre
    3
        Glucose : <2.2 (F) and <2.8 (M) millimoles/Litre
    3
        Activated Partial Thromboplastin Time : >70 second
    3
        Prothrombin Time : >25 seconds
    2
        Sodium : >155 millimoles/Litre
    2
        Chloride : <90 millimoles/Litre
    2
        Alanine Aminotransferase : >3*ULN
    1
        Erythrocytes (10^12/L) : <3.1
    1
        Potassium : >6.5 millimoles/Litre
    1
        Glucose : >22.2 millimoles/Litre
    1
    No statistical analyses for this end point

    Primary: Incidence of markedly abnormal changes in electrocardiograms (ECGs)

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    End point title
    Incidence of markedly abnormal changes in electrocardiograms (ECGs) [3]
    End point description
    A routine 12-lead ECG was performed at all visits. The ECG included heart rate, PR, QRS, and QT intervals assessment. The data are presented for the Safety Analysis Set.
    End point type
    Primary
    End point timeframe
    For the overall 52-week Treatment Period
    Notes
    [3] - 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: The data were presented using descriptive statistics. No statistical analysis was performed.
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Number of patients
    3
    No statistical analyses for this end point

    Primary: Incidence of markedly abnormal changes in body weight and vital signs

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    End point title
    Incidence of markedly abnormal changes in body weight and vital signs [4]
    End point description
    Vital signs were measured at all visits and included blood pressure (BP: measured after the patient had been in a seated position for ≥3 minutes of rest), pulse, respiration rate, body temperature, and body weight. The data are presented for the Safety Analysis Set.
    End point type
    Primary
    End point timeframe
    For the overall 52-week Treatment Period
    Notes
    [4] - 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: The data were presented using descriptive statistics. No statistical analysis was performed.
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Number of patients
        Temperature - <35 degree celsius
    2
        Diastolic BP - >105 mmHg
    2
        Diastolic BP - <50 mmHg
    1
        Systolic BP - <85 mmHg
    1
    No statistical analyses for this end point

    Primary: Number of patients using concomitant medications

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    End point title
    Number of patients using concomitant medications [5]
    End point description
    The concomitant medications details were collected throughout the trial at all visits. Data were obtained at scheduled or unscheduled trial visits based on information provided spontaneously by the patient or as a result of questioning the patient. The data are presented for the Safety Analysis Set.
    End point type
    Primary
    End point timeframe
    For the overall 52-week Treatment Period
    Notes
    [5] - 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: The data were presented using descriptive statistics. No statistical analysis was performed.
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Number of patients
    340
    No statistical analyses for this end point

    Secondary: Use of concomitant over-the-counter (OTC) laxatives

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    End point title
    Use of concomitant over-the-counter (OTC) laxatives
    End point description
    The use of OTC laxatives during the trial was assessed based upon the concomitant medication module of the electronic Case Report Form (eCRF). The data are presented for the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    For the overall 52-week Treatment Period
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Number of patients
        Contact laxatives
    33
        Osmotically acting laxatives
    14
        Softeners, Emollients
    11
        Bulk Producers
    6
        Enemas
    1
    No statistical analyses for this end point

    Secondary: Change from Baseline in global evaluation of constipation severity

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    End point title
    Change from Baseline in global evaluation of constipation severity
    End point description
    The constipation severity score was measured on a 5-point scale (1: none to 5: very severe). The data are presented for the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    At Week 12, 24, 36, and 52
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        At Week 12
    -0.2 ± 1.1
        At Week 24
    -0.2 ± 1.1
        At Week 36
    -0.1 ± 1.11
        At Week 52
    -0.2 ± 1.08
    No statistical analyses for this end point

    Secondary: Change from Baseline in global evaluation of treatment effectiveness

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    End point title
    Change from Baseline in global evaluation of treatment effectiveness
    End point description
    The treatment effectiveness score was measured on a 5-point scale (1: extremely effective, 2: quite a bit effective, 3: moderately effective, 4: little bit effective, 5: not at all effective). The data are presented for the the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    At Week 12, 24, 36, and 52
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        At Week 12
    -0.6 ± 1.43
        At Week 24
    -0.6 ± 1.36
        At Week 36
    -0.7 ± 1.24
        At Week 52
    -0.7 ± 1.22
    No statistical analyses for this end point

    Secondary: Change from Baseline in Patient assessment of constipation - Quality of Life (PAC-QOL): Overall score

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    End point title
    Change from Baseline in Patient assessment of constipation - Quality of Life (PAC-QOL): Overall score
    End point description
    PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific QOL. The questionnaire is based on a 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better QOL. The PAC-QOL questionnaire is developed specifically for patients with constipation. PAC-QOL has four sub-scales: ‘Worries and Concerns’, ‘Physical Discomfort’, ‘Psychosocial Discomfort’, and ‘Dissatisfaction’. The data are presented for the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    At Week 12, 24, 36 and 52
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        At Week 12
    -0.24 ± 0.677
        At Week 24
    -0.21 ± 0.639
        At Week 36
    -0.16 ± 0.687
        At Week 52
    -0.22 ± 0.644
    No statistical analyses for this end point

    Secondary: Change from Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) scores

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    End point title
    Change from Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) scores
    End point description
    EQ-5D-5L is a standardised measure of health status developed to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels (1-5 denotes): no problems, slight problems, moderate problems, severe problems, and extreme problems, respectively. A unique health state was defined by combining 1 level from each of the 5 dimensions. Each health state was converted into a single EQ-5D-5L index value. The index values are country specific and values specified for United Kingdom (UK) were used for this study. The index value range for UK lies between -0.594 - 1.000. A positive index value represents better health status while the negative value represents poor health status. The data are presented for the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    At Week 12, 24, 36 and 52
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        At Week 12
    0 ± 0.14
        At Week 24
    0 ± 0.14
        At Week 36
    0 ± 0.15
        At Week 52
    0 ± 0.15
    No statistical analyses for this end point

    Secondary: Change from Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) score

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    End point title
    Change from Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) score
    End point description
    The EQ VAS presents the participant's self-evaluated health on a 20 cm vertical, visual analogue scale with endpoints labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’. This scale is numbered from 0 to 100, where '100' means best health you can imagine and '0' means worst health you can imagine. The participant simply mark an 'X' on the scale to indicate "how his/her health is TODAY" and mention the same number in a box provided. The data are presented for the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    At Week 12, 24, 36 and 52
    End point values
    EBX10
    Number of subjects analysed
    409
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        At Week 12
    0.7 ± 13.43
        At Week 24
    1.2 ± 11.95
        At Week 36
    1 ± 12.44
        At Week 52
    0.8 ± 12.35
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For the overall 52-week Treatment Period and the 2-week Follow-up Period
    Adverse event reporting additional description
    The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. Visit 6 - the end of the follow-up period) in the AEs Log . During the trial, a total of 26 patients were down-titrated to 5 mg a day and most of these had diarrhea.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    EBX 10
    Reporting group description
    Elobixibat 10 mg Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.

    Serious adverse events
    EBX 10
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 409 (3.42%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphangioma
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Emotional distress
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Breast abscess
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 409 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    EBX 10
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 409 (18.83%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    57 / 409 (13.94%)
         occurrences all number
    69
    Abdominal pain
         subjects affected / exposed
    28 / 409 (6.85%)
         occurrences all number
    31

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Nov 2013
    The majority of the changes in this amendment were clarifications to the initial protocol (dated 21 Feb 2013 in all participating countries except in the UK where the original protocol was dated 24 May 2013). The changes included e.g. adjustments of secondary analyses and endpoints, adjustment of exclusion criteria, clarification of administration and documentation of first IMP intake, and correction of wording and minor errors. This amendment was applicable for all sites.
    24 Feb 2014
    The main change in this amendment was the updated inclusion and exclusion criteria following the termination of the lead in efficacy trials (Echo 1 and Echo 2; protocols 000079 and 000080, respectively), to allow eligible patients to roll over into this trial (Echo 3) at the earliest convenience, and without interruption of treatment. Amendment 3 for South Africa corresponds to amendment 2 for all other participating countries. This amendment was applicable for all sites in South Africa.
    12 Sep 2014
    The main change in this amendment was the updated recruitment projections for this trial due to Sponsor's early termination of the lead in efficacy trials (Echo 1 and Echo 2; protocols 000079 and 000080, respectively) that significantly lowered the number of potential patients who could roll over into this trial. This amendment was applicable for all sites.

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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