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

Completed

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

• Registration Number: NCT00738205
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2009-03
• Study Completion: 2009-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-10
• Last Update Posted: 2014-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 834

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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