Status:
COMPLETED
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Growth Hormone Deficiency
Turner Syndrome
Eligibility:
All Genders
2-17 years
Brief Summary
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 a...
Detailed Description
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 chang...
Eligibility Criteria
Inclusion
- Already treated patients who are dissatisfied with their current self-injection device, or naïve pediatric patients, in cases for which this indication is validated (growth hormone deficiency, Turner's syndrome, chronic renal failure, small-for-gestational age \[SGA\] patients, based on RCP)
Exclusion
- Cases in which Saizen® is contra-indicated (based on local RCP)
- Children returning for consultation, who have not brought back their Easypod™ electronic self-injector.
- Children who are participating in a therapeutic trial, or who have done so in the 3-month period preceding their recruitment into this observational study
Key Trial Info
Start Date :
June 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
834 Patients enrolled
Trial Details
Trial ID
NCT00738205
Start Date
June 1 2007
End Date
June 1 2009
Last Update
March 11 2014
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