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Saizen® E-Device User Trial

This study has been completed.

Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov Identifier: NCT00450190
  Purpose

This 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.


Condition Intervention Phase
Growth Disorders
Device: Electronic device; Electronic Auto-Injector of Saizen®
Phase III

MedlinePlus related topics:   Growth Disorders   

ChemIDplus related topics:   Somatotropin    Somatropin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • To evaluate patients’ feedback on the use of E-Device by using a questionnaire: To evaluate the nurse/physician’s feedback after the E-Device set up at the inclusion visit and To assess the safety during the treatment and follow-up period of the study [ Time Frame: Various time points ]

Enrollment:   81
Study Start Date:   January 2006
Study Completion Date:   September 2006

  Eligibility
Genders Eligible for Study:   Both

Criteria

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 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450190

Sponsors and Collaborators
EMD Serono

Investigators
Study Director:     Dominique Roger, MD     Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany    
  More Information


Full FDA approved prescribing information can be found here  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   26443
First Received:   March 21, 2007
Last Updated:   June 11, 2007
ClinicalTrials.gov Identifier:   NCT00450190
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by EMD Serono:
Growth disorders/drug therapy  

Study placed in the following topic categories:
Growth Disorders

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on September 19, 2008




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