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    Clinical Trial Results:
    Multicentre study to evaluate the efficacy and safety of a liquid formulation of recombinant growth hormone, Omnitrope® 3.3mg/mL, in the treatment of pre-pubertal children of small stature suffering from somatotropin deficiency (GH) – phase IIIb

    Summary
    EudraCT number
    		 2015-002802-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    31 Jul 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Mar 2016
    First version publication date
    31 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Sandoz/OMNI/F/01/03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sandoz S.A.S
    Sponsor organisation address
    49, avenue Georges Pompidou, Levallois-Perret Cedex, France, 92300
    Public contact
    Strategic Planning Biopharma Clinical Development, Sandoz, 0049 80244760, biopharma.cliniclatrials@sandoz.com
    Scientific contact
    Strategic Planning Biopharma Clinical Development, Sandoz, 0049 80244760, biopharma.cliniclatrials@sandoz.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Nov 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and tolerance of Omnitrope® 3.3 mg/ml injection, administered at a dose of 0.23 mg/kg/week, in terms of clinical and immunological parameters, and laboratory test results.
    Protection of trial subjects
    Before the patient embarked on the study, the Investigator was obliged to explain clearly to every Patient/Family/Legal Representative the nature and objectives of the clinical trial, its benefits and risks, their rights and the confidentiality of the data, before providing a copy of the Information Sheet to read and keep. At the Pre-Inclusion Visit, after the Patient/Family/Legal Representative had familiarised themselves with the information provided, the Investigator asked them to give their agreement in writing by dating page and signing the Informed Consent Form. For the Amendments that entailed changes to the Information Sheet and Informed Consent Form, the Investigator had to get new Forms signed and dated by every Patient/Family/Legal Representative.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2003
    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
    France: 53
    Worldwide total number of subjects
    53
    EEA total number of subjects
    53
    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)
    53
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 100 patients should have been recruited in 41 French sites, due to slow recruitment 51 patients where enrolled in 23 sites first patient first visit 20 Oct 2003 last patient first visit 13 Nov 2006 last patient last visit 31 Jul 2008.

    Pre-assignment
    Screening details
    		 53 patients were screened, 2 patients didn't meet the screening criteria and were therefore not included in the study due to either violation of inclusion criteria or growth hormone test not showing deficiency

    Pre-assignment period milestones
    Number of subjects started
    		 53
    Number of subjects completed
    		 51

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 2
    Period 1
    Period 1 title
    Treatment Phase up to Month 12
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All patients
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omnitrope®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Omnitrope® 3.3 mg/mL injection administered subcutaneously using an injector pen with ready-to-use 1.5 ml cartridges. Included patients were given a dosage of 0.23 mg/kg/week, i.e. 0.033 mg/kg/day injected once daily for 12 months.

    Number of subjects in period 1 [1]
    		All patients
    Started
    51
    Completed
    51
    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: 2 patients were screened but not enrolled into the trial
    Period 2
    Period 2 title
    Treatment Phase Month 12 - 24
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NAP

    Arms
    Arm title
    		 All patients
    Arm description
    		 This study phase was already voluntary for the patients. Therefore 51 started and only 41 ended it.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omnitrope®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Omnitrope® 3.3 mg/mL injection administered subcutaneously using an injector pen with ready-to-use 1.5 ml cartridges. Included patients were given a dosage of 0.23 mg/kg/week, i.e. 0.033 mg/kg/day injected once daily for 12 months.

    Number of subjects in period 2
    		All patients
    Started
    51
    Completed
    41
    Not completed
    10
         Consent withdrawn by subject
    1
         Unknown but no AE
    5
         Switch to commercialised product
    3
         Lack of efficacy
    1
    Period 3
    Period 3 title
    Treatment Phase Month 24 - 36
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NAP

    Arms
    Arm title
    		 All patients
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omnitrope®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Omnitrope® 3.3 mg/mL injection administered subcutaneously using an injector pen with ready-to-use 1.5 ml cartridges. Included patients were given a dosage of 0.23 mg/kg/week, i.e. 0.033 mg/kg/day injected once daily for 12 months.

    Number of subjects in period 3
    		All patients
    Started
    41
    Completed
    24
    Not completed
    17
         Unknown but no AE
    8
         Lost to follow-up
    2
         Switch to commercialised product
    4
         Lack of efficacy
    1
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Phase up to Month 12
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Phase up to Month 12 Total
    Number of subjects
    		 51 51
    Age categorical
    Patients where devided into 3 agegroup
    Units: Subjects
        < 4 years
    		 7 7
        [4-8) years
    		 27 27
        >= 8 years
    		 17 17
    Age continuous
    children with the age of 1.19 to 11.62 years were included into the study
    Units: years
        arithmetic mean (full range (min-max))
    		 6.87 (1.33 to 11.82) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 42 42
    Scan of brain
    MR examination of the brain, with centralised reading for the results
    Units: Subjects
        Normal
    		 1 1
        Not done
    		 50 50
    MRI brain
    Units: Subjects
        Normal
    		 20 20
        Abnormal
    		 16 16
        Not done
    		 15 15
    Gestational Age [weeks]
    Units: weeks
        arithmetic mean (full range (min-max))
    		 39.22 (34 to 46) -
    Birth height
    Units: cm
        arithmetic mean (full range (min-max))
    		 47.96 (42 to 51) -
    Birth weight
    Units: gram(s)
        arithmetic mean (full range (min-max))
    		 3110 (1420 to 4760) -
    Cranial perimeter
    Units: cm
        arithmetic mean (full range (min-max))
    		 34.53 (31 to 38.5) -
    Father's height
    Units: cm
        arithmetic mean (full range (min-max))
    		 171.7 (155 to 193.5) -
    Age of father's puberty
    Units: years
        arithmetic mean (full range (min-max))
    		 14.11 (12.6 to 17) -
    Mother's height
    Units: cm
        arithmetic mean (full range (min-max))
    		 158.12 (139.5 to 174) -
    Age of mother's first menstruation
    Units: years
        arithmetic mean (full range (min-max))
    		 13.21 (10.6 to 17) -
    Weight
    Units: kg
        arithmetic mean (full range (min-max))
    		 17.91 (8.3 to 34.5) -
    BMI
    Units: kg/cm2
        arithmetic mean (full range (min-max))
    		 15.35 (12.12 to 25.38) -
    Height
    Units: cm
        arithmetic mean (full range (min-max))
    		 106.49 (73 to 134) -
    Height SDS
    height minus standard height of the respective age devided by standard deviation for the respective age of the standard population
    Units: SDS
        arithmetic mean (full range (min-max))
    		 -2.39 (-4.03 to -1.47) -

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -
    Reporting group title
    All patients
    Reporting group description
    		 This study phase was already voluntary for the patients. Therefore 51 started and only 41 ended it.
    Reporting group title
    All patients
    Reporting group description
    		 -

    Primary: Height velocity after 12 months

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    End point title
    		 Height velocity after 12 months [1]
    End point description
    Height velocity is calculated in cm/year by dividing the difference in two height readings by the interval of time between the measurements and multiplying by 365.25. To ensure accurate estimation of height and growth rate, each patient was measured three times at each Visit by the same Investigator using the same graduated height gauge. The height recorded represents the mean of these three measurements.
    End point type
    Primary
    End point timeframe
    12 months
    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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    51
    Units: cm/year
    arithmetic mean (standard deviation)
        Height velocity month 12
    9.66 ( 2.14 )
    No statistical analyses for this end point

    Primary: Height velocity after 24 months

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    End point title
    		 Height velocity after 24 months [2]
    End point description
    Height velocity is calculated in cm/year by dividing the difference in two height readings by the interval of time between the measurements and multiplying by 365.25. To ensure accurate estimation of height and growth rate, each patient was measured three times at each Visit by the same Investigator using the same graduated height gauge. The height recorded represents the mean of these three measurements.
    End point type
    Primary
    End point timeframe
    Month 12 to month 24
    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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    41
    Units: cm/year
    arithmetic mean (standard deviation)
        Height velocity month 24
    8.65 ( 1.42 )
    No statistical analyses for this end point

    Primary: Height velocity after 36 months

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    End point title
    		 Height velocity after 36 months [3]
    End point description
    Height velocity is calculated in cm/year by dividing the difference in two height readings by the interval of time between the measurements and multiplying by 365.25. To ensure accurate estimation of height and growth rate, each patient was measured three times at each Visit by the same Investigator using the same graduated height gauge. The height recorded represents the mean of these three measurements.
    End point type
    Primary
    End point timeframe
    Month 24 to 36
    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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    24
    Units: cm/year
    arithmetic mean (standard deviation)
        Height velocity month 36
    8.2 ( 1 )
    No statistical analyses for this end point

    Primary: Height velocity SDS after 12 months

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    End point title
    		 Height velocity SDS after 12 months [4]
    End point description
    Height velocity is calculated in cm/year by dividing the difference in two height readings by the interval of time between the measurements and multiplying by 365.25. Increase in height velocity SDS (related to chronological age and gender) SDS values are calculated for height velocity using the following equation: SDS = X1 – X2 / SD in which X1 is the actual measurement, X2 is the norm for that chronological age (CA) (or bone age, if appropriate) and SD is the standard deviation at that age. To ensure accurate estimation of height and growth rate, each patient was measured three times at each Visit by the same Investigator using the same graduated height gauge. The height recorded represents the mean of these three measurements.
    End point type
    Primary
    End point timeframe
    Baseline to month 12
    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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    51
    Units: SDS/year
    arithmetic mean (standard deviation)
        Height velocity SDS month 12
    4.66 ( 3.07 )
    No statistical analyses for this end point

    Primary: Heigth velocity SDS after 24 months

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    End point title
    		 Heigth velocity SDS after 24 months [5]
    End point description
    Height velocity is calculated in cm/year by dividing the difference in two height readings by the interval of time between the measurements and multiplying by 365.25. Increase in height velocity SDS (related to chronological age and gender) SDS values are calculated for height velocity using the following equation: SDS = X1 – X2 / SD in which X1 is the actual measurement, X2 is the norm for that chronological age (CA) (or bone age, if appropriate) and SD is the standard deviation at that age. To ensure accurate estimation of height and growth rate, each patient was measured three times at each Visit by the same Investigator using the same graduated height gauge. The height recorded represents the mean of these three measurements.
    End point type
    Primary
    End point timeframe
    month 12 to 24
    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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    41
    Units: SDS/year
    arithmetic mean (standard deviation)
        Height velocity SDS month 24
    3.45 ( 2.2 )
    No statistical analyses for this end point

    Primary: Heigth velocity SDS after 36 months

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    End point title
    		 Heigth velocity SDS after 36 months [6]
    End point description
    Height velocity is calculated in cm/year by dividing the difference in two height readings by the interval of time between the measurements and multiplying by 365.25. Increase in height velocity SDS (related to chronological age and gender) SDS values are calculated for height velocity using the following equation: SDS = X1 – X2 / SD in which X1 is the actual measurement, X2 is the norm for that chronological age (CA) (or bone age, if appropriate) and SD is the standard deviation at that age. To ensure accurate estimation of height and growth rate, each patient was measured three times at each Visit by the same Investigator using the same graduated height gauge. The height recorded represents the mean of these three measurements.
    End point type
    Primary
    End point timeframe
    month 24 to 36
    Notes
    [6] - 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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    24
    Units: SDS/year
    arithmetic mean (standard deviation)
        Height velocity SDS month 36
    2.55 ( 2.01 )
    No statistical analyses for this end point

    Primary: Height gain after 12 months

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    End point title
    		 Height gain after 12 months [7]
    End point description
    Height gain expressed in cm
    End point type
    Primary
    End point timeframe
    Baseline to month 12
    Notes
    [7] - 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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    51
    Units: cm
    arithmetic mean (standard deviation)
        Heigth gain month 12
    9.67 ( 1.84 )
    No statistical analyses for this end point

    Primary: Heigth gain after 24 months

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    End point title
    		 Heigth gain after 24 months [8]
    End point description
    height gain expressed in cm
    End point type
    Primary
    End point timeframe
    Month 12 to 24
    Notes
    [8] - 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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    41
    Units: cm
    arithmetic mean (standard deviation)
        Height gain month 24
    17.04 ( 2.75 )
    No statistical analyses for this end point

    Primary: Height gain after 36 months

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    End point title
    		 Height gain after 36 months [9]
    End point description
    height gain expressed in cm
    End point type
    Primary
    End point timeframe
    Month 24 to 36
    Notes
    [9] - 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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    24
    Units: cm
    arithmetic mean (standard deviation)
        Height gain month 36
    24.6 ( 3.21 )
    No statistical analyses for this end point

    Primary: Height gain SDS

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    End point title
    		 Height gain SDS [10]
    End point description
    Standard Deviation Score (SDS) which is based on the difference between the mean value for normal children of the same gender at that chronological age. SDS values are calculated for height using the following equation: SDS = X1 – X2 / SD in which X1 is the actual measurement, X2 is the norm for that chronological age (CA) (or bone age, if appropriate) and SD is the standard deviation at that age.
    End point type
    Primary
    End point timeframe
    Baseline to month 12
    Notes
    [10] - 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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    51
    Units: SDS
    arithmetic mean (standard deviation)
        Height gain SDS month 12
    -1.48 ( 0.65 )
    No statistical analyses for this end point

    Primary: Height gain SDS after 24 months

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    End point title
    		 Height gain SDS after 24 months [11]
    End point description
    Standard Deviation Score (SDS) which is based on the difference between the mean value for normal children of the same gender at that chronological age. SDS values are calculated for height using the following equation: SDS = X1 – X2 / SD in which X1 is the actual measurement, X2 is the norm for that chronological age (CA) (or bone age, if appropriate) and SD is the standard deviation at that age.
    End point type
    Primary
    End point timeframe
    Month 12 to 24
    Notes
    [11] - 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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    41
    Units: SDS
    arithmetic mean (standard deviation)
        Heigth gain SDS month 24
    -0.97 ( 0.61 )
    No statistical analyses for this end point

    Primary: Height gain SDS after 36 months

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    End point title
    		 Height gain SDS after 36 months [12]
    End point description
    Standard Deviation Score (SDS) which is based on the difference between the mean value for normal children of the same gender at that chronological age. SDS values are calculated for height using the following equation: SDS = X1 – X2 / SD in which X1 is the actual measurement, X2 is the norm for that chronological age (CA) (or bone age, if appropriate) and SD is the standard deviation at that age.
    End point type
    Primary
    End point timeframe
    Month 24 to 36
    Notes
    [12] - 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 whole study was performed only with descriptive analysis.
    End point values
    		 All patients
    Number of subjects analysed
    24
    Units: cm
    arithmetic mean (standard deviation)
        Height gain SDS month 36
    -0.71 ( 0.71 )
    No statistical analyses for this end point

    Secondary: IGF-1 baseline to month 12

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    End point title
    		 IGF-1 baseline to month 12
    End point description
    Increases in IGF-1 levels were calculated every six months. Changes in IGF-1 levels were evaluated for each individual patient and for all subjects.
    End point type
    Secondary
    End point timeframe
    Baseline to month 12
    End point values
    		 All patients
    Number of subjects analysed
    51
    Units: ng/mL
    arithmetic mean (standard deviation)
        Baseline
    64.88 ( 54.18 )
        Month 6
    172.4 ( 127 )
        Month 12
    193.5 ( 103.3 )
    No statistical analyses for this end point

    Secondary: IGF-1 month 12 to month 24

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    End point title
    		 IGF-1 month 12 to month 24
    End point description
    Increases in IGF-1 levels were calculated every six months. Changes in IGF-1 levels were evaluated for each individual patient and for all subjects.
    End point type
    Secondary
    End point timeframe
    Month 12 to 24
    End point values
    		 All patients
    Number of subjects analysed
    45
    Units: ng/mL
    arithmetic mean (standard deviation)
        Month 18
    208.5 ( 79.12 )
        Month 24
    241.2 ( 113 )
    No statistical analyses for this end point

    Secondary: IGF-1 month 24 to month 36

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    End point title
    		 IGF-1 month 24 to month 36
    End point description
    Increases in IGF-1 levels were calculated every six months. Changes in IGF-1 levels were evaluated for each individual patient and for all subjects.
    End point type
    Secondary
    End point timeframe
    Month 24 to 36
    End point values
    		 All patients
    Number of subjects analysed
    25
    Units: ng/mL
    arithmetic mean (standard deviation)
        Month 36
    234.5 ( 169.8 )
    No statistical analyses for this end point

    Secondary: IGF-1 SDS baseline to month 12

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    End point title
    		 IGF-1 SDS baseline to month 12
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to month 12
    End point values
    		 All patients
    Number of subjects analysed
    51
    Units: SDS
    arithmetic mean (standard deviation)
        Baseline
    -1.28 ( 1.26 )
        Month 6
    0.58 ( 1.77 )
        Month 12
    0.6 ( 1.48 )
    No statistical analyses for this end point

    Secondary: IGF-1 SDS month 12 to month 24

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    End point title
    		 IGF-1 SDS month 12 to month 24
    End point description
    End point type
    Secondary
    End point timeframe
    Month 12 to 24
    End point values
    		 All patients
    Number of subjects analysed
    45
    Units: SDS
    arithmetic mean (standard deviation)
        Month 18
    0.91 ( 1.5 )
        Month 24
    0.6 ( 1.55 )
    No statistical analyses for this end point

    Secondary: IGF-1 SDS month 36

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    End point title
    		 IGF-1 SDS month 36
    End point description
    End point type
    Secondary
    End point timeframe
    Month 24 to 36
    End point values
    		 All patients
    Number of subjects analysed
    25
    Units: SDS
    arithmetic mean (standard deviation)
        Month 36
    0.44 ( 2.01 )
    No statistical analyses for this end point

    Secondary: Antibodies against GH - Baseline and Month 12

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    End point title
    		 Antibodies against GH - Baseline and Month 12
    End point description
    Immunological safety was assessed by assaying for antibodies against GH at a central laboratory. This endpoint was analysed even for patients that dropped out of the study.
    End point type
    Secondary
    End point timeframe
    24 Months - assessments where done at baseline, at month 12 and at month 24
    End point values
    		 All patients
    Number of subjects analysed
    50
    Units: Negative / positive
        Negative - Baseline
    44
        Missing - Baseline
    6
        Negative - Month 12
    42
        Missing - Month 12
    8
    No statistical analyses for this end point

    Secondary: Antibodies against GH - Month 24

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    End point title
    		 Antibodies against GH - Month 24
    End point description
    Immunological safety was assessed by assaying for antibodies against GH at a central laboratory. This endpoint was analysed even for patients that dropped out of the study.
    End point type
    Secondary
    End point timeframe
    24 Months - assessments where done at baseline, at month 12 and at month 24
    End point values
    		 All patients
    Number of subjects analysed
    41
    Units: Negative / Positive
        Negative - Month 24
    25
        Missing - Month 24
    16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    51 subjects were exposed to the treatment for 12 months, 43 for 18 months, 41 for 24 months and 24 for 36 months, representing about 1400 subject*months
    Adverse event reporting additional description
    The following assessments were made at each Visit: • Local tolerance at the injection site. • Systemic tolerance through the recording of Adverse Events and concomitant treatments
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 51 (3.92%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Appendectomy
    Additional description: Appendectomy was performed on 7 May and his hospital stay lasted from 7 - 14 May 2005. During this time, the treatment was interrupted. The Investigator judged the relationship between the event and the Study Treatment as Improbable.
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
    Additional description: Constipation was diagnosed; he was given an enema and put on Fortax and Spasfon. He completely recovered and was discharged on 17 March 2006. The Investigator judged that no related to study treatment
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 51 (82.35%)
    Investigations
    Glycosylated haemoglobin increased
         subjects affected / exposed
    6 / 51 (11.76%)
         occurrences all number
    6
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    10 / 51 (19.61%)
         occurrences all number
    10
    Gastrointestinal disorders
    Pharyngitis
         subjects affected / exposed
    8 / 51 (15.69%)
         occurrences all number
    8
    Respiratory, thoracic and mediastinal disorders
    Rhinitis
         subjects affected / exposed
    9 / 51 (17.65%)
         occurrences all number
    9
    Cough
         subjects affected / exposed
    6 / 51 (11.76%)
         occurrences all number
    6
    Infections and infestations
    Ear infection
         subjects affected / exposed
    9 / 51 (17.65%)
         occurrences all number
    9
    Acute tonsilitis
         subjects affected / exposed
    6 / 51 (11.76%)
         occurrences all number
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 May 2004
    Methodological change: increased dose for non-responders in the second year of treatment; change to the Information Sheet; and updating of the list of Investigating Centres
    14 Dec 2004
    Methodological change: change in the central laboratory for anti-GH antibody assays; change in the volumes of blood to be drawn; change of the injector-pen and to the related Questionnaire; date of the preliminary statistical analysis put back (from 30 April 2005 to a later, as yet unfixed date, due to the low inclusion rate); change to the Information Sheet; updating of the list of Investigating Centres; and modification of the Sponsor's legal status.
    10 Jan 2006
    Extension of the inclusion period by one year, through 31 December 2006; changes in the section on SAEs; updating of the Investigator's Brochure (N° 11 of 25 May 2005); and updating of the list of Investigating Centres

    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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