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Saizen® E-Device User Trial

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00450190
First received: March 21, 2007
Last updated: August 11, 2011
Last verified: August 2011
History of Changes

March 21, 2007
August 11, 2011
February 2006
September 2006   (final data collection date for primary outcome measure)
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 ]
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
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 ]
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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
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Growth Disorders
Device: Electronic device; Electronic Auto-Injector of Saizen®
Not Provided
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. 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
September 2006
September 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 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
Both
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Contact information is only displayed when the study is recruiting subjects
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NCT00450190
26443
Not Provided
Medical Director, Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA
Not Provided
Study Director: Dominique Roger, MD Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA
August 2011

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