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Completed

NCT Number: NCT00450190

Saizen® E-Device User Trial

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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Key information

Conditions

Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saizen® E-Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 22, 2007
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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