Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A monocentric, randomized, placebo-controlled double-blind clinical trial to assess the efficacy of Selenium in Morbus Basedow

    Summary
    EudraCT number
    		 2010-022840-19
    Trial protocol
    		 DE  
    Global end of trial date
    26 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2020
    First version publication date
    26 Jan 2020
    Other versions
    Summary report(s)
    		 doi: 10.1210/jc.2017-01736 J Clin Endocrinol Metab, November 2017, 102(11):4333–4341

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SEBA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Center Mainz
    Sponsor organisation address
    Langenbeckstreet 1, Mainz, Germany,
    Public contact
    Principal Investigator, University Medical Center Mainz, Dept. of Medicine I, 49 6131172290, kahaly@ukmainz.de
    Scientific contact
    Principal Investigator, Universitätsmedizin Mainz, Dept. of Medicine I, 49 6131172290, kahaly@ukmainz.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 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - Response rate at week 24: comparison of the combination treatment of anti-thyroid drug and selenium vs. anti-thyroid monotherapy (compared to baseline). Response rate is defined by euthyroidism: normal fT3, fT4 and TSH and negative TSH-R-Ab. - Relapse rate at week 36 (in both groups): Relapse rate is defined by change of thyroid related hormones and -antibodies (TSH, fT3, fT4, TSH-R-Ab) compared to week 24.
    Protection of trial subjects
    Patients were evaluated at baseline and 4, 12, 24 and 36 weeks after starting treatment. Secondary outcomes were safety and tolerability of Se and MMI. Adverse events (AEs) were coded according to the standardized Medical Dictionary for Regulatory Activities (26) as recommended by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (27). AEs were analyzed for alternative causes and judged for relatedness to intake of Se (side effects).AEs were followed up until a stable outcome could be documented or until the patient was lost to follow-up.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jan 2012
    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: 70
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    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)
    66
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Baseline assessments (general medical history, laboratory tests, physical examination, vital signs and thyroid investigations) could be performed up to 2 weeks before baseline (Screening period). Results must be available and negative prior to administration of medication.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Blinding took place after the baseline period

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Baseline 1
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet per day

    Arm title
    		 Selenium
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selenium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet per day

    Number of subjects in period 1
    		Baseline 1 Selenium
    Started
    35
    35
    Completed
    35
    35
    Period 2
    Period 2 title
    Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    A computer program generated a list and randomly allocated a patient number to one of the two treatment arms, starting with 001. Those numbers were also printed on the patient packs, packages, and blister cards, containing Se or placebo tablets, depending on the assigned number. Patients and site staff as well as monitors and clinical trial coordinators were blinded to identity of the Treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet per day

    Arm title
    		 Selenium
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selenium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet per day

    Number of subjects in period 2
    		Placebo Selenium
    Started
    35
    35
    Completed
    33
    31
    Not completed
    2
    4
         sublinical hyperthyroidism
    -
    1
         Consent withdrawn by subject
    -
    2
         Pregnancy
    1
    -
         Lost to follow-up
    1
    1

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Baseline 1
    Reporting group description
    		 -

    Reporting group title
    Selenium
    Reporting group description
    		 -
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Selenium
    Reporting group description
    		 -

    Primary: Response rate at week 24

    		 Close Top of page
    End point title
    		 Response rate at week 24
    End point description
    End point type
    Primary
    End point timeframe
    baseline to week 24
    End point values
    		 Placebo Selenium
    Number of subjects analysed
    33
    31
    Units: patients
    27
    25
    Statistical analysis title
    		 Primary outcome
    Statistical analysis description
    Primary outcome response at week 24 was defined for each patient who appeared at the week 24 visit.
    Comparison groups
    Placebo v Selenium
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05 [2]
    Method
    		 Fisher exact
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
    Notes
    [1] - Comparison
    [2] - All reported P values are two-sided. Significance level was set at 0.05.

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    From Baseline to visit 36 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Safety Analysis
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Frequency threshold for reporting non-serious adverse Events was set at 5%. No AE occurred in more than 3 patients; a detailed safety analysis is given in the attached manuscript
    Serious adverse events
    		 Safety Analysis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 70 (11.43%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Riding accident
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Eyelid operation
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast operation
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhoid operation
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    anal sphincter repair
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    tachyarrhytmia absoluta
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    opticus neuropathy
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    hyperglycemia
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Analysis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 70 (0.00%)

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jul 2013
    Number of patients was increased from 50 to 70

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

    European Medicines Agency © 1995-Fri May 03 05:29:58 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA