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Saizen® E-Device User Trial

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ClinicalTrials.gov Identifier: NCT00450190
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

March 21, 2007
March 22, 2007
September 29, 2017
July 23, 2018
July 23, 2018
February 28, 2006
September 30, 2006   (Final data collection date for primary outcome measure)
  • Subjects' Overall Impression After Using E-Device [ Time Frame: 2 Weeks ]
    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 [ Time Frame: 2 Weeks ]
    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.
To evaluate patients' feedback after 2 weeks of E-Device use with a questionnaire (by phone) on qualitative first global impression of the E-Device and on usefulness and reliability of each E-Device function
Complete list of historical versions of study NCT00450190 on ClinicalTrials.gov Archive Site
  • Subjects' Feedback Immediately After Initial Training During Inclusion Visit [ Time Frame: Inclusion visit (Day 1) ]
    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 [ Time Frame: Inclusion visit (Day 1) ]
    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) [ Time Frame: Day 1 up to Day 90 ]
    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.
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Saizen® E-Device User Trial
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
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.
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Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Growth Disorders
Device: Saizen® E-Device
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.
Experimental: Saizen® E-Device
Intervention: Device: Saizen® E-Device
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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September 30, 2006
September 30, 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
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Contact information is only displayed when the study is recruiting subjects
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NCT00450190
26443
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Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany
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Study Director: Medical Responsible Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP