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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Small for Gestational Age; Chronic Renal Failure; Turner Syndrome; Growth Hormone Deficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT00738205

Easypod

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 834 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

834 participants in 2 patient groups

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