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

Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector When Administering Saizen® Growth Hormone to Children With Growth Disorders

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00738205

Enrollment

834

Registered

2008-08-20

Start date

2007-06-30

Completion date

2009-06-30

Last updated

2014-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure, Growth Hormone Deficiency, Small for Gestational Age, Turner Syndrome

Keywords

Electronic device, Growth hormone treatment

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

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame
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.	week 12

Secondary

Measure	Time frame
To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen.	week 12

Outcome results