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    Clinical Trial Results:
    A Multicenter, Open-Label, Randomized, Two Arm Cross-Over Study Assessing Dyad (Subject and Caregiver) and Adult Subject Perception of Convenience and Preference of the Newly Developed Genotropin Mark VII Pen

    Summary
    EudraCT number
    2009-017354-12
    Trial protocol
    SE   CZ   SK   DE   GB   NL  
    Global end of trial date
    26 Oct 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Mar 2016
    First version publication date
    09 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A6281297
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01112865
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 1 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 1 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.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
    09 Mar 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the ease of use or convenience of the new Genotropin Mark VII pen compared to the current Genotropin Pen.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    Comparison of subject acceptance of the Genotropin Mark VII pen and the current marketed Genotropin pen.
    Actual start date of recruitment
    06 Aug 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 13
    Country: Number of subjects enrolled
    Sweden: 14
    Country: Number of subjects enrolled
    Turkey: 20
    Country: Number of subjects enrolled
    United Kingdom: 17
    Country: Number of subjects enrolled
    Czech Republic: 32
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Netherlands: 5
    Worldwide total number of subjects
    120
    EEA total number of subjects
    100
    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)
    51
    Adolescents (12-17 years)
    27
    Adults (18-64 years)
    40
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 120 subjects were screened from 23 centers of 7 countries worldwide and all subjects were included in the trial. Study started on 06 August 2010 and completed on 26 October 2011.

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

    Arms
    Arm title
    Entire Study Population
    Arm description
    Included all subjects which were randomized to use either the Mark VII pen first or the current Genotropin® pen first.
    Arm type
    Experimental

    Investigational medicinal product name
    Genotropin Mark VII pen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects randomized to use the Mark VII pen subcutaneous injections daily for 2 months. Pen provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]), doses received by subjects based on body weight.

    Investigational medicinal product name
    Genotropin Pen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects randomized to use the current Genotropin® pen subcutaneous injections daily for 2 months. Pen provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]), doses received by subjects based on body weight.

    Number of subjects in period 1
    Entire Study Population
    Started
    120
    Completed
    120

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    -

    Reporting group values
    Overall study Total
    Number of subjects
    120 120
    Age categorical
    Included all subjects which were randomized to use either the Mark VII pen first or the current Genotropin® pen first.
    Units: Subjects
        Less than or equal to (<=) 7 years
    28 28
        Between 8 and 17 years
    50 50
        Between 18 and 44 years
    18 18
        Between 45 and 64 years
    22 22
        Greater than or equal to (>=) 5 years
    2 2
    Gender categorical
    Units: Subjects
        Female
    51 51
        Male
    69 69

    End points

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    End points reporting groups
    Reporting group title
    Entire Study Population
    Reporting group description
    Included all subjects which were randomized to use either the Mark VII pen first or the current Genotropin® pen first.

    Subject analysis set title
    Mark VII Pen
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects who used the Mark VII pen any time during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]), doses were received by subjects based on body weight.

    Subject analysis set title
    Genotropin® Pen
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects who used the current Genotropin® pen anytime during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses were received by subjects based on body weight.

    Primary: Percentage of Dyads (Subject and Caregiver or Parent) and Adult Subjects Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®

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    End point title
    Percentage of Dyads (Subject and Caregiver or Parent) and Adult Subjects Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® [1]
    End point description
    Subjects were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference. Full Analysis Set (FAS): randomized subjects who used a study pen at least once to administer somatropin. Dyad defined as the subject (child being treated) and adult partner (parent or caregiver).
    End point type
    Primary
    End point timeframe
    Month 4
    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: Only descriptive data was planned to be reported for this end point.
    End point values
    Entire Study Population
    Number of subjects analysed
    119 [2]
    Units: percentage of dyads, adult subjects
        number (confidence interval 95%)
    67.23 (58.79 to 75.66)
    Notes
    [2] - Number of subjects analyzed (N)= subjects with evaluable data.
    No statistical analyses for this end point

    Secondary: Percentage of Dyads and Adult Subjects Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®

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    End point title
    Percentage of Dyads and Adult Subjects Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®
    End point description
    Subjects were asked the following question from Section II of the IPAQ PRO tool, "Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall." Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference. FAS population.
    End point type
    Secondary
    End point timeframe
    Month 4
    End point values
    Entire Study Population
    Number of subjects analysed
    120
    Units: percentage of dyads, adult subjects
        number (confidence interval 95%)
    64.17 (55.59 to 72.75)
    No statistical analyses for this end point

    Secondary: Percentage of Dyads and Adult Subjects Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®

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    End point title
    Percentage of Dyads and Adult Subjects Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®
    End point description
    Subjects were asked the following question from Section II of the IPAQ PRO tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference. FAS population.
    End point type
    Secondary
    End point timeframe
    Month 4
    End point values
    Entire Study Population
    Number of subjects analysed
    119 [3]
    Units: percentage of dyads, adult subjects
        number (confidence interval 95%)
    51.26 (42.28 to 60.24)
    Notes
    [3] - Number of subjects analyzed (N)= subjects with evaluable data.
    No statistical analyses for this end point

    Secondary: Percentage of Dyads and Adult Subjects Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®

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    End point title
    Percentage of Dyads and Adult Subjects Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®
    End point description
    Subjects were asked the following question from Section II of the IPAQ PRO tool, "Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall." Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference. FAS population.
    End point type
    Secondary
    End point timeframe
    Month 4
    End point values
    Entire Study Population
    Number of subjects analysed
    120
    Units: percentage of dyads, adult subjects
        number (confidence interval 95%)
    54.17 (45.25 to 63.08)
    No statistical analyses for this end point

    Secondary: Percentage of Dyads and Adult Subjects Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen

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    End point title
    Percentage of Dyads and Adult Subjects Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen
    End point description
    Investigators were asked the following study treatment continuation question, "Which device did the subject choose for continued treatment?" Choices included the Genotropin® Pen or the new injection pen. FAS subset of subjects located in areas where the new device was available.
    End point type
    Secondary
    End point timeframe
    Month 4
    End point values
    Entire Study Population
    Number of subjects analysed
    55
    Units: percentage of dyads, adult subjects
        number (confidence interval 95%)
    47.27 (34.08 to 60.47)
    Attachments
    Statistical Analysis
    No statistical analyses for this end point

    Secondary: Ease of Use of Each Injection Pen

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    End point title
    Ease of Use of Each Injection Pen
    End point description
    Subjects were asked the following question from Section I of the IPAQ PRO tool, “Thinking about the injection pen you have been using for the past few months, how easy or difficult it is for you to use the injection pen overall?” Responses were provided using a 5 point scale which ranged from very easy (5), somewhat easy (4), neither easy nor difficult (3), somewhat difficult (2), or very difficult (1). FAS population.
    End point type
    Secondary
    End point timeframe
    Month 2 and Month 4
    End point values
    Mark VII Pen Genotropin® Pen
    Number of subjects analysed
    119 [4]
    119 [5]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    4.5 ± 0.64
    4.2 ± 0.71
    Notes
    [4] - Number of subjects analyzed (N)= subjects with evaluable data.
    [5] - Number of subjects analyzed (N)= subjects with evaluable data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 7 days after last dose
    Adverse event reporting additional description
    The same event may appear as both an adverse event (AE) and a serious AE (SAE). An event may be categorized as serious in one subject and as nonserious in another subject. EU BR specific AE tables were generated separately as per EU format. Latest coding dictionary has been used for EU BR tables.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Safety Population
    Reporting group description
    All randomized participants who used a study pen (Genotropin® pen or the new Mark VII injection pen) at least once to administer Genotropin.

    Serious adverse events
    Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 120 (1.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    1 / 120 (0.83%)
         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
    Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 120 (40.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Foot fracture
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 120 (2.50%)
         occurrences all number
    3
    Oropharyngeal pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    11 / 120 (9.17%)
         occurrences all number
    26
    Paraesthesia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    2
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Injection site bruising
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Injection site haemorrhage
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Injection site injury
         subjects affected / exposed
    4 / 120 (3.33%)
         occurrences all number
    12
    Injection site pain
         subjects affected / exposed
    4 / 120 (3.33%)
         occurrences all number
    13
    Injection site reaction
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    3
    Vertigo
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Psychiatric disorders
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Food poisoning
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Inguinal hernia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Myalgia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    3 / 120 (2.50%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 120 (5.83%)
         occurrences all number
    8
    Otitis media
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Otitis media acute
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Pharyngitis
         subjects affected / exposed
    4 / 120 (3.33%)
         occurrences all number
    4
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Viral infection
         subjects affected / exposed
    6 / 120 (5.00%)
         occurrences all number
    7

    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.
    None reported
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