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Saizen® E-Device User Trial

Primary Purpose

Growth Disorders

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Saizen® E-Device
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Disorders focused on measuring Growth disorders

Eligibility Criteria

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Inclusion Criteria:

  1. Patients naïve to, or experienced with, Saizen® with growth disorders in registered indications (GHD, Turner's Syndrome, Chronic Renal Failure, patient born Small Gestational Age [SGA] according to the local SmPC)
  2. Written informed consent must be obtained from the parent(s)/legal guardian(s) at the beginning of the study. Children able to understand the trial should personally sign and date the written informed consent

Exclusion Criteria:

  1. Known hypersensitivity to somatropin or any of the excipients
  2. Epiphyseal fusion
  3. Active neoplasia (either newly diagnosed or recurrent)
  4. History of intracranial hypertension with papilledema
  5. Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose > 116 mg/dL
  6. Severe congenital malformations
  7. Severe psychomotor retardation
  8. Known hepatic disease as defined by elevated liver enzymes or total bilirubin (x 2 N)
  9. Current congestive heart failure, untreated hypertension, serious chronic oedema of any cause
  10. Chronic infectious disease
  11. Previous or ongoing treatment with sex steroid therapy such as estrogens and testosterone
  12. Previous or ongoing treatment with any therapy that may directly influence growth, including GH, GHRF and long duration corticosteroids therapy
  13. Proliferative or preproliferative diabetic retinopathy
  14. Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
  15. Precocious puberty
  16. Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia
  17. Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
  18. Participation to any clinical study within the 30 days preceding study entry
  19. Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Saizen® E-Device

    Arm Description

    Outcomes

    Primary Outcome Measures

    Subjects' Overall Impression After Using E-Device
    Subjects' overall impression after using E-Device was measured on a scale ranging from 1 to 3, where 1 = bad, 2 = good, and 3 = very good. Number of subjects with response based on overall impression scale were presented.
    Usefulness and Reliability of E-Device Functions
    Following functions were assessed: Display of remaining dose in cartridge, Display of last injection date and time, Automatic needle attachment, Audible and visual signals, Dose injected confirmation, Dose history, Customizable needle insertion speed, Customizable drug insertion speed, Customizable insertion depth, Teach me menu, On screen instructions, Customizable name and picture, Pre-programmed dose and Skin sensor. Usefulness and reliability of each of the E-Device functions was measured on a scale ranging from 1 to 3, where 1 = not useful, 2 = useful, and 3 = very useful. Number of subjects with response based on usefulness and reliability scale were presented.

    Secondary Outcome Measures

    Subjects' Feedback Immediately After Initial Training During Inclusion Visit
    Subjects' feedback immediately after initial training on the handling and use of E-Device was assessed on scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Subjects were provided training on the following aspects: Cartridge loading, Needle attachment, Needle detachment, Injection process, Navigation in the menu, and Handling of the device. Number of subjects with response based on their feedback were presented.
    Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
    Nurse/physician's feedback was assessed for E-Device setting up and Dose programming on inclusion visit using a scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Nurse/Physician's response for the number of subjects were presented.
    Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)
    An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.

    Full Information

    First Posted
    March 21, 2007
    Last Updated
    September 29, 2017
    Sponsor
    Merck KGaA, Darmstadt, Germany
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00450190
    Brief Title
    Saizen® E-Device User Trial
    Official Title
    User Trial on the Use in Common Practice of a New Electronic Auto-injector of Saizen®, the E-Device (Electronic Device), in Children Treated by Recombinant Human Growth Hormone Over a Period of 2 Months
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 28, 2006 (Actual)
    Primary Completion Date
    September 30, 2006 (Actual)
    Study Completion Date
    September 30, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck KGaA, Darmstadt, Germany

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of the study is to evaluate the E-Device performances and handling on the use in common practice, by collecting the impressions of patients, nurses and the investigator on the graphic interface, the instructions manual, the E-Device training and the material itself.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Growth Disorders
    Keywords
    Growth disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Saizen® E-Device
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Saizen® E-Device
    Intervention Description
    Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) will be administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.
    Primary Outcome Measure Information:
    Title
    Subjects' Overall Impression After Using E-Device
    Description
    Subjects' overall impression after using E-Device was measured on a scale ranging from 1 to 3, where 1 = bad, 2 = good, and 3 = very good. Number of subjects with response based on overall impression scale were presented.
    Time Frame
    2 Weeks
    Title
    Usefulness and Reliability of E-Device Functions
    Description
    Following functions were assessed: Display of remaining dose in cartridge, Display of last injection date and time, Automatic needle attachment, Audible and visual signals, Dose injected confirmation, Dose history, Customizable needle insertion speed, Customizable drug insertion speed, Customizable insertion depth, Teach me menu, On screen instructions, Customizable name and picture, Pre-programmed dose and Skin sensor. Usefulness and reliability of each of the E-Device functions was measured on a scale ranging from 1 to 3, where 1 = not useful, 2 = useful, and 3 = very useful. Number of subjects with response based on usefulness and reliability scale were presented.
    Time Frame
    2 Weeks
    Secondary Outcome Measure Information:
    Title
    Subjects' Feedback Immediately After Initial Training During Inclusion Visit
    Description
    Subjects' feedback immediately after initial training on the handling and use of E-Device was assessed on scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Subjects were provided training on the following aspects: Cartridge loading, Needle attachment, Needle detachment, Injection process, Navigation in the menu, and Handling of the device. Number of subjects with response based on their feedback were presented.
    Time Frame
    Inclusion visit (Day 1)
    Title
    Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
    Description
    Nurse/physician's feedback was assessed for E-Device setting up and Dose programming on inclusion visit using a scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Nurse/Physician's response for the number of subjects were presented.
    Time Frame
    Inclusion visit (Day 1)
    Title
    Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)
    Description
    An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.
    Time Frame
    Day 1 up to Day 90

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: Patients naïve to, or experienced with, Saizen® with growth disorders in registered indications (GHD, Turner's Syndrome, Chronic Renal Failure, patient born Small Gestational Age [SGA] according to the local SmPC) Written informed consent must be obtained from the parent(s)/legal guardian(s) at the beginning of the study. Children able to understand the trial should personally sign and date the written informed consent Exclusion Criteria: Known hypersensitivity to somatropin or any of the excipients Epiphyseal fusion Active neoplasia (either newly diagnosed or recurrent) History of intracranial hypertension with papilledema Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose > 116 mg/dL Severe congenital malformations Severe psychomotor retardation Known hepatic disease as defined by elevated liver enzymes or total bilirubin (x 2 N) Current congestive heart failure, untreated hypertension, serious chronic oedema of any cause Chronic infectious disease Previous or ongoing treatment with sex steroid therapy such as estrogens and testosterone Previous or ongoing treatment with any therapy that may directly influence growth, including GH, GHRF and long duration corticosteroids therapy Proliferative or preproliferative diabetic retinopathy Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion Precocious puberty Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment Participation to any clinical study within the 30 days preceding study entry Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Responsible
    Organizational Affiliation
    Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18589398
    Citation
    Tauber M, Payen C, Cartault A, Jouret B, Edouard T, Roger D. User trial of Easypod, an electronic autoinjector for growth hormone. Ann Endocrinol (Paris). 2008 Dec;69(6):511-6. doi: 10.1016/j.ando.2008.04.003. Epub 2008 Jun 26.
    Results Reference
    result
    Links:
    URL
    http://www.saizenus.com
    Description
    Full FDA approved prescribing information can be found here

    Learn more about this trial

    Saizen® E-Device User Trial

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