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   43862   clinical trials with a EudraCT protocol, of which   7285   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:
    PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQ USING A NOVEL CAPILLARY BLOOD COLLECTION METHOD (OPTIMA)

    Summary
    EudraCT number
    		 2004-000356-17
    Trial protocol
    		 ES   IT   DK   AT   SE   FI  
    Global end of trial date
    22 Jul 2008

    Results information
    Results version number
    		 v1
    This version publication date
    23 Mar 2016
    First version publication date
    23 Mar 2016
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2-79-58035700
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00234533
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Beaufour Ipsen Pharma
    Sponsor organisation address
    24, rue Erlanger, Paris Cedex 16, France, 75781
    Public contact
    Medical Director, Pediatric Endocrinology , Ipsen, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Pediatric Endocrinology, Ipsen, clinical.trials@ipsen.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
    22 Jul 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jul 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish an optimal monitoring regimen for IGF-I in NutropinAq treated children, using a newly developed capillary blood spot IGF-I measurements technology.
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2004
    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
    Belgium: 8
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    France: 86
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Romania: 16
    Country: Number of subjects enrolled
    Russian Federation: 52
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Ukraine: 30
    Worldwide total number of subjects
    251
    EEA total number of subjects
    169
    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)
    3
    Children (2-11 years)
    145
    Adolescents (12-17 years)
    103
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment period: 12 months.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 251
    Number of subjects completed
    		 248

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 Patient’s height did not meet screening criteria: 1
    Reason: Number of subjects
    		 Not included based on the Investigator’s decision: 1
    Period 1
    Period 1 title
    Patients receiving study medication
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 NutropinAq 10 mg/2 ml (30 IU)
    Arm description
    		 NutropinAq 10 mg/2 ml (30 IU) subcutaneous injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    NutropinAq
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    NutropinAq 10 mg/2 ml (30 IU) injection subcutaneously

    Number of subjects in period 1
    		NutropinAq 10 mg/2 ml (30 IU)
    Started
    248
    Completed
    244
    Not completed
    4
         Withdrawn due to AE
    1
         Withdrawal of consent and other
    3
    Period 2
    Period 2 title
    NutropinAq 10 mg/2 ml (30 IU)
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 NutropinAq 10 mg/2 ml (30 IU)
    Arm description
    		 NutropinAq 10 mg/2 ml (30 IU) subcutaneous injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    NutropinAq
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    NutropinAq 10 mg/2 ml (30 IU) injection subcutaneously

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 is Patients receiving study medication (all patients who received at least one injection of treatment) and period 2 is ITT population [the ITT population was all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data]. As the ITT population is considered for demographic representation in the study, period 2 is the choice of group.
    Number of subjects in period 2 [2]
    		NutropinAq 10 mg/2 ml (30 IU)
    Started
    244
    Completed
    240
    Not completed
    4
         Withdrawn due to AE
    1
         Withdrawal of consent
    3
    Notes
    [2] - 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: Screened population is 251, the three screen failure subjects were excluded from the study and patients receiving study medication is 248.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    NutropinAq 10 mg/2 ml (30 IU)
    Reporting group description
    		 NutropinAq 10 mg/2 ml (30 IU) subcutaneous injection.

    Reporting group values
    		 NutropinAq 10 mg/2 ml (30 IU) Total
    Number of subjects
    		 244 244
    Age categorical
    Units: Subjects
        Number of subjects
    		 244 244
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.9 ± 3.9 -
    Gender categorical
    Units: Subjects
        Female
    		 138 138
        Male
    		 106 106
    Birth height
    Units: cm
        arithmetic mean (standard deviation)
    		 48.49 ± 3.36 -
    Birth weight
    Units: kg
        arithmetic mean (standard deviation)
    		 2.94 ± 0.64 -
    Duration of gestation (weeks of amenorrhea)
    Units: weeks
        arithmetic mean (standard deviation)
    		 38.7 ± 2.6 -
    Genetic target height
    Units: cm
        arithmetic mean (standard deviation)
    		 166.26 ± 8.16 -
    Calculated genetic target height SDS
    Units: SD
        arithmetic mean (standard deviation)
    		 -0.33 ± 0.95 -
    Growth Hormone (GH)
    Units: years
        arithmetic mean (standard deviation)
    		 1.68 ± 1.56 -
    Auxological Parameter - Height
    Units: cm
        arithmetic mean (standard deviation)
    		 122.95 ± 20.24 -
    Auxological Parameter - Calculated height SDS
    Units: SD
        arithmetic mean (standard deviation)
    		 -2.68 ± 1.33 -
    Auxological Parameter - Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 27.97 ± 11.91 -
    Auxological Parameter - Calculated weight SDS
    Units: SD
        arithmetic mean (standard deviation)
    		 -1.85 ± 1.88 -
    Auxological Parameter - Annualised GV
    Units: cm/year
        arithmetic mean (standard deviation)
    		 4.94 ± 2.56 -
    Auxological Parameter - Calculated annualised GV SDS
    Units: SD
        arithmetic mean (standard deviation)
    		 -0.56 ± 2.67 -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    NutropinAq 10 mg/2 ml (30 IU)
    Reporting group description
    		 NutropinAq 10 mg/2 ml (30 IU) subcutaneous injection
    Reporting group title
    NutropinAq 10 mg/2 ml (30 IU)
    Reporting group description
    		 NutropinAq 10 mg/2 ml (30 IU) subcutaneous injection

    Subject analysis set title
    NutropinAq 10 mg/2 ml (30 IU) – Morning
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-to-Treat (ITT) population: The ITT population was all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.

    Subject analysis set title
    NutropinAq 10 mg/2 ml (30 IU) – Evening
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-to-Treat (ITT) population: The ITT population was all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.

    Primary: Timed Capillary Blood Spot IGF-I Measurements

    		 Close Top of page
    End point title
    		 Timed Capillary Blood Spot IGF-I Measurements [1]
    End point description
    Intention-to-Treat (ITT) population: The ITT population was all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. The Intra Class Correlation (ICC) was calculated each of the 2 series (morning and evening) of IGF1 measurements (weeks 21, 22 & 23).
    End point type
    Primary
    End point timeframe
    At week 21, 22 and 23
    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: An one-way Analysis of Covariance (ANCOVA) was used to calculate between patient variation and within patient variation and then to calculate ICC and its confidence limits. An ICC ≥0.8 was considered satisfactory and indicated that a single sample was representative of the overall IGF-I status. For overall ITT Population Intra-class Correlation Coefficient [95% confidence intervals] in morning was 0.92 (0.90; 0.93) and in evening was 0.90 (0.88; 0.92).
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU) – Morning NutropinAq 10 mg/2 ml (30 IU) – Evening
    Number of subjects analysed
    244
    244
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 21 (n=226, 230)
    223.54 ± 161.86
    212.97 ± 153.61
        Week 22 (n=223, 229)
    238.02 ± 177.89
    226.9 ± 164.38
        Week 23 (n=226, 225)
    241.58 ± 167.75
    235.47 ± 168.48
    No statistical analyses for this end point

    Secondary: Factors Affecting the Variability of Timed Capillary Blood Spots: Influence of week and daily timing (evening and morning)

    		 Close Top of page
    End point title
    		 Factors Affecting the Variability of Timed Capillary Blood Spots: Influence of week and daily timing (evening and morning)
    End point description
    The influence of daily timing on IGF-I measurements was tested in three-way analyses of variance with patient, day and daily timing as factors after appropriate transformation to obtain normally distributed parameters. The interaction day*time was tested and kept in the model only if p-value <0.1. The values listed are parameter estimate. Method used for estimation was ANOVA. p-value for weeks was 0.1678 and p value for morning/evening was 0.3035.
    End point type
    Secondary
    End point timeframe
    At week 21, 22 and 23
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: ng/ml
    least squares mean (confidence interval 95%)
        Week 21
    218.3 (203 to 233.5)
        Week 22
    232.4 (217.1 to 247.8)
        Week 23
    238.5 (223.2 to 253.9)
        Timing: Evening
    225.1 (212.6 to 237.6)
        Timing: Morning
    234.4 (221.8 to 246.9)
    No statistical analyses for this end point

    Secondary: Factors Affecting the Variability of Timed Capillary Blood Spots: Influence of sex, age and prepubertal status

    		 Close Top of page
    End point title
    		 Factors Affecting the Variability of Timed Capillary Blood Spots: Influence of sex, age and prepubertal status
    End point description
    Analysis of covariance model taking into account the week, time of the day as well as age, sex and pubertal status of the patients. The values listed are parameter estimate. Method used for estimation was ANCOVA. p-value for Age was <0.001, Sex was <0.001 and Pubertal stage was <0.001.
    End point type
    Secondary
    End point timeframe
    At week 21, 22, and 23
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: ng/ml
    least squares mean (confidence interval 95%)
        Female
    234.4 (224.7 to 244.4)
        Male
    172.1 (162.7 to 181.9)
        Pubertal
    238.9 (224.8 to 253.5)
        Prepubertal
    168.4 (160.7 to 176.3)
    No statistical analyses for this end point

    Secondary: Factors Affecting the Variability of Timed Capillary Blood Spots: Influence of individual factors/Multivariate linear regression analysis.

    		 Close Top of page
    End point title
    		 Factors Affecting the Variability of Timed Capillary Blood Spots: Influence of individual factors/Multivariate linear regression analysis.
    End point description
    The within-patient coefficient of variation was computed from the series of 6 measurements(Week 21,Week 22,Week 23). The multivariate linear regression analyses was used to derive an explanatory model of WCV: age,sex,diseasecondition,dose expressed in mg/kg/d at V1,pubertal stage (genital development for boys/ breast development for girls and pubic hair),height and weight SDS at baseline, compliance(evaluated from the patient's diary),time of the year(all patients were not tested at the same time of the year),sample taken on a week day or a weekend day and country(country clusters were:1 France;2 Spain, Greece, Romania and Italy;3 UK, Belgium, Czech Republic, Denmark, Germany, Slovakia, Austria and Finland;4 Russia;5 Ukraine). These variables were tested using a stepwise forward-backward elimination (with a significance level of p=0.15 for adding and keeping a term in the final model). Values listed are p-values and method is Regression, linear
    End point type
    Secondary
    End point timeframe
    Up to week 24
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: NA
    number (not applicable)
        Disease condition
    0.0012
        Country cluster
    0.0701
    No statistical analyses for this end point

    Secondary: Factors Affecting the Variability of Timed Capillary Blood Spots: Influence of time of year and calculated age at enrolment and Disease condition.

    		 Close Top of page
    End point title
    		 Factors Affecting the Variability of Timed Capillary Blood Spots: Influence of time of year and calculated age at enrolment and Disease condition.
    End point description
    PP Population: The per protocol (PP) population was all patients in the ITT population for whom no major protocol violations/deviations occurred. Analysis of covariance model taking into account the time of year, calculated age at enrolment and disease condition. Values listed are p-values and method is ANCOVA.
    End point type
    Secondary
    End point timeframe
    Up to week 24
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: NA
    number (not applicable)
        Time of the year
    0.0139
        Calculated age at enrolment
    0.0073
        Disease condition
    0.0511
    No statistical analyses for this end point

    Secondary: Precision Profile of Capillary Blood Random Spot versus Serum IGF-I

    		 Close Top of page
    End point title
    		 Precision Profile of Capillary Blood Random Spot versus Serum IGF-I
    End point description
    This is the correlation between capillary blood random spot IGF-I measurements and serum IGF-I assay. The reported value is r (correlation coefficient)
    End point type
    Secondary
    End point timeframe
    Up to week 24
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: NA
        number (not applicable)
    0.73
    No statistical analyses for this end point

    Secondary: IGFBP3 Measurements

    		 Close Top of page
    End point title
    		 IGFBP3 Measurements
    End point description
    End point type
    Secondary
    End point timeframe
    At Visit 1 (Day 0), Visit 2 (Month 3) and Visit 3 (Month 6)
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: ng/mL
    arithmetic mean (standard deviation)
        Visit 1 (n=241)
    4786.8 ± 1777.5
        Change from baseline at visit 2 (n=235)
    1112.4 ± 1321.4
        Change from baseline at visit 3 (n=230)
    1285.2 ± 1350.9
    No statistical analyses for this end point

    Secondary: Auxological Parameter - Height

    		 Close Top of page
    End point title
    		 Auxological Parameter - Height
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 3 (month 6)
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: cm
    arithmetic mean (standard deviation)
        Height: Change from baseline at Visit 3
    4.73 ± 1.69
    No statistical analyses for this end point

    Secondary: Auxological Parameter - Weight

    		 Close Top of page
    End point title
    		 Auxological Parameter - Weight
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 3 (month 6)
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: kg
    arithmetic mean (standard deviation)
        Weight: Change from baseline at Visit 3
    2.01 ± 1.87
    No statistical analyses for this end point

    Secondary: Auxological Parameter - Annualised GV

    		 Close Top of page
    End point title
    		 Auxological Parameter - Annualised GV
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 3 (month 6)
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: cm/year
    arithmetic mean (standard deviation)
        Annualised GV: Change from baseline at Visit 3
    5.2 ± 4.72
    No statistical analyses for this end point

    Secondary: Acceptability and Tolerance of NutropinAq and its Administration Device: NutropinAq Pen

    		 Close Top of page
    End point title
    		 Acceptability and Tolerance of NutropinAq and its Administration Device: NutropinAq Pen
    End point description
    This details is for Overall handling of pen
    End point type
    Secondary
    End point timeframe
    Up to week 22
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: Percentage of subjects
    number (not applicable)
        Overall handling of pen - Very Easy
    39.8
        Overall handling of pen - Easy
    52.5
        Overall handling of pen - Moderately difficult
    3.3
        Overall handling of pen - Difficult
    0
        Overall handling of pen - Very difficult
    0.4
        Overall handling of pen - Missing
    4.1
    No statistical analyses for this end point

    Secondary: Safety Evaluation - Posology

    		 Close Top of page
    End point title
    		 Safety Evaluation - Posology
    End point description
    The posology adopted at the first visit is summarized. Safety population
    End point type
    Secondary
    End point timeframe
    Up to week 24
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    248
    Units: mg/kg/day
    arithmetic mean (standard deviation)
        Posology
    0.0382 ± 0.0092
    No statistical analyses for this end point

    Secondary: Safety Evaluation - Extent of Exposure

    		 Close Top of page
    End point title
    		 Safety Evaluation - Extent of Exposure
    End point description
    The treatment exposure, defined as the number of daily injections recorded is summarized. Safety population
    End point type
    Secondary
    End point timeframe
    Up to week 24
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    248
    Units: days
    arithmetic mean (standard deviation)
        Study Exposure
    159.7 ± 35.8
    No statistical analyses for this end point

    Secondary: Auxological Parameter - Calculated Height SDS

    		 Close Top of page
    End point title
    		 Auxological Parameter - Calculated Height SDS
    End point description
    The French growth charts (according to Sempé) were used for the calculation of SDS parameters.
    End point type
    Secondary
    End point timeframe
    At visit 3 (month 6)
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: SD
    arithmetic mean (standard deviation)
        Calculated height: Change from baseline at Visit 3
    0.45 ± 0.37
    No statistical analyses for this end point

    Secondary: Auxological Parameter - Calculated Weight SDS

    		 Close Top of page
    End point title
    		 Auxological Parameter - Calculated Weight SDS
    End point description
    The French growth charts (according to Sempé) were used for the calculation of SDS parameters.
    End point type
    Secondary
    End point timeframe
    At visit 3 (month 6)
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: SD
    arithmetic mean (standard deviation)
        Calculated weight: Change from baseline at Visit
    0.2 ± 0.56
    No statistical analyses for this end point

    Secondary: Auxological Parameter - Calculated annualised GV SDS

    		 Close Top of page
    End point title
    		 Auxological Parameter - Calculated annualised GV SDS
    End point description
    The French growth charts (according to Sempé) were used for the calculation of SDS parameters.
    End point type
    Secondary
    End point timeframe
    At visit 3 (month 6)
    End point values
    		 NutropinAq 10 mg/2 ml (30 IU)
    Number of subjects analysed
    244
    Units: SD
    arithmetic mean (standard deviation)
        Calculated annualised GV: Month 6
    5.1 ± 4.8
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to week 24
    Adverse event reporting additional description
    NutropinAq 10 mg/2 ml (30 IU) subcutaneous injection.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    NutropinAq 10 mg/2 ml (30 IU)
    Reporting group description
    		 -

    Serious adverse events
    		 NutropinAq 10 mg/2 ml (30 IU)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 248 (2.42%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Retinitis pigmentosa
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 NutropinAq 10 mg/2 ml (30 IU)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    84 / 248 (33.87%)
    Vascular disorders
    Wound haemorrhage
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences all number
    3
    Face oedema
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Feeling cold
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Hyperthermia
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Injection site bruising
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences all number
    2
    Injection site oedema
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Injection site pain
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    9 / 248 (3.63%)
         occurrences all number
    10
    Respiratory, thoracic and mediastinal disorders
    Allergic bronchitis
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Pharyngolaryngeal Pain
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Investigations
    Insulin-like growth factor increased
         subjects affected / exposed
    13 / 248 (5.24%)
         occurrences all number
    13
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Arthropod bite
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Arthropod sting
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Femur fracture
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Foot fracture
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Hand fracture
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences all number
    2
    Wound complication
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Retinitis pigmentosa
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 248 (5.65%)
         occurrences all number
    27
    Migraine
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Auricular swelling
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 248 (1.61%)
         occurrences all number
    4
    Abdominal pain upper
         subjects affected / exposed
    4 / 248 (1.61%)
         occurrences all number
    5
    Aptyalism
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences all number
    4
    Gastritis
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences all number
    3
    Stomatitis
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    5 / 248 (2.02%)
         occurrences all number
    8
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences all number
    2
    Swelling face
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences all number
    2
    Thyroiditis acute
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences all number
    3
    Back pain
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences all number
    3
    Pain in extremity
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences all number
    4
    Pubic pain
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Scoliosis
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Bronchitis Acute
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences all number
    3
    Bronchopneumonia
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences all number
    2
    Cellulitis
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    2
    Enterovirus infection
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences all number
    2
    Gastroenteritis viral
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences all number
    4
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences all number
    3
    Nasopharyngitis
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences all number
    3
    Otitis media
         subjects affected / exposed
    5 / 248 (2.02%)
         occurrences all number
    6
    Pyelonephritis acute
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    6 / 248 (2.42%)
         occurrences all number
    6
    Scarlet fever
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences all number
    2
    Tonsillitis bacterial
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 248 (2.82%)
         occurrences all number
    10
    Viral infection
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    2
    Hyperglycaemia
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1
    Polydipsia
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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.
    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 Apr 26 16:16:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA