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    The EU Clinical Trials Register currently displays   41231   clinical trials with a EudraCT protocol, of which   6758   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Clinical Trial Results:
    A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults

    Summary
    EudraCT number
    2004-004835-72
    Trial protocol
    GB  
    Global end of trial date
    23 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Aug 2020
    First version publication date
    28 Aug 2020
    Other versions
    Summary report(s)
    Summary 2004-004835-72

    Trial information

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    Trial identification
    Sponsor protocol code
    RG_05-161
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Birmingham
    Sponsor organisation address
    Edgbaston, Birmingham, United Kingdom, B15 2TT
    Public contact
    Research Governance Team, University of Birmingham, researchgovernance@contacts.bham.ac.uk
    Scientific contact
    Research Governance Team, University of Birmingham, researchgovernance@contacts.bham.ac.uk
    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
    23 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the impact of growth hormone replacement therapy on quality of Life in adults with severe growth hormone deficiency
    Protection of trial subjects
    Inclusion criteria: Aged over 18 Able to provide informed consent Severe GH deficiency in adult life No GH replacement therapy for six months Other hormone replacement therapy stable over previous six months Life expectancy >15 months Exclusion criteria: Active malignant disease Active Cushings disease or acromegaly Pregnancy Proliferative diabetic retinopathy Sensitivity to GH or its preservative Breast feeding
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 May 2005
    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
    United Kingdom: 88888
    Worldwide total number of subjects
    88888
    EEA total number of subjects
    88888
    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)
    0
    From 65 to 84 years
    0
    85 years and over
    88888

    Subject disposition

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    Recruitment
    Recruitment details
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.

    Pre-assignment
    Screening details
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.

    Arms
    Arm title
    Overall
    Arm description
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.
    Arm type
    n/a

    Investigational medicinal product name
    Growth Hormone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.

    Number of subjects in period 1
    Overall
    Started
    88888
    Completed
    88888

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.

    Reporting group values
    Overall Total
    Number of subjects
    88888 88888
    Age categorical
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.
    Units: Subjects
        Not applicable
    88888 88888
    Gender categorical
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.
    Units: Subjects
        Not applicable
    88888 88888

    End points

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    End points reporting groups
    Reporting group title
    Overall
    Reporting group description
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.

    Primary: Not applicable

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    End point title
    Not applicable [1]
    End point description
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.
    End point type
    Primary
    End point timeframe
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified as the trial was terminated early. After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.
    End point values
    Overall
    Number of subjects analysed
    88888 [2]
    Units: n/a
    88888
    Notes
    [2] - 88888 is referring to not applicable due to the data integrity issues.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    n/a
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: No adverse events have been specified as the trial was terminated early. After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.

    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.
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain.
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