Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector
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|ClinicalTrials.gov Identifier: NCT00738205|
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : March 11, 2014
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.
|Condition or disease|
|Growth Hormone Deficiency Turner Syndrome Chronic Renal Failure Small for Gestational Age|
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.
|Study Type :||Observational|
|Actual Enrollment :||834 participants|
|Official Title:||Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector When Administering Saizen® Growth Hormone to Children With Growth Disorders|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||June 2009|
- 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 ]
- To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen. [ Time Frame: week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738205
|Study Director:||Clément Olivier, MD, LMCC||Merck Serono S.A., Geneva|