CompletedNot Applicable

Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector

834 participantsStarted 2007-06

Plain-language 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 after 12 week of use. Both children naïve to growth hormone and dissatisfied with their current injection device will be recruited.

Who can participate

Age range2 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

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.

Timeframe: week 12

Trial details

NCT IDNCT00738205

SponsorMerck KGaA, Darmstadt, Germany

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2009-03

View on ClinicalTrials.gov More Growth Hormone Deficiency trials