NCT00738205

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
• Phase: —
• Study type: Observational
• Enrollment: 834 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-03-01
• Completion: 2009-06-01
• First posted: 2008-08-20
• Last updated: 2014-03-11