NCT00689260

Easypod United States User Trial

A Randomized, Multicenter, 3 Month Phase IV Study to Evaluate the Effect on Subject Adherence With Injection Schedule by Using the Easypod™ rhGH Delivery Device

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study will help to determine whether an injection log on a recombinant human growth hormone (rhGH) delivery device improves subjects' adherence with injection schedules. Adherence will be compared between a group of subjects who are aware of the injection log on the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™ injection log. It is the study hypothesis that subject non-adherence rate is different for those who are aware of the injection log capability versus those who are unaware of the injection log capability. Subject perception will also be evaluated by comparing the ease and convenience of use and subject preference for the easypod™ compared to two other rhGH pen injection devices.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DEVICE	easypod	Subjects is aware that the device records injection information that can be viewed by user
DEVICE	easypod	Subjects is not aware that the device records injection information that can be viewed by user

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-05-01
• Completion: 2009-10-01
• First posted: 2008-06-03
• Last updated: 2015-05-15
• Results posted: 2010-07-20

Locations

1 site across 1 country: United States