Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector
This is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use.
Both children naïve to growth hormone and dissatisfied with their current injection device will be recruited.
Growth Hormone Deficiency
Chronic Renal Failure
Small for Gestational Age
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector When Administering Saizen® Growth Hormone to Children With Growth Disorders|
- To assess children's compliance with the Saizen®, growth hormone treatment, following introduction of the new easypodTM self-injector, while comparing newly treated and previously treated children. [ Time Frame: week 12 ] [ Designated as safety issue: No ]
- To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen. [ Time Frame: week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
An international, multicenter cross-sectional study (Observatoire des pratiques médicales®) involving a cohort of children treated with Saizen®, a growth hormone.
The study does not require any changes to the usual medical management of these patients and should not be considered detrimental to their physical or psychological integrity. No specific procedures or examinations will be requested, nor does the protocol require any particular treatment or follow-up visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738205
|Study Director:||Clément Olivier, MD, LMCC||Merck Serono S.A., Geneva|