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Sponsored by: |
EMD Serono |
Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00450190 |
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 |
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 |
Enrollment: | 81 |
Study Start Date: | January 2006 |
Study Completion Date: | September 2006 |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Full FDA approved prescribing information can be found here 
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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 |
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