CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
easypod +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00689260
NCT00689260Phase 4Completed

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

EMD Serono·interventional·Posted Jun 3, 2008·Updated May 15, 2015

In Brief

A Phase 4 clinical trial evaluating easypod for Growth Hormone Deficiency. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 3, 2008
Enrollment StartMar 1, 2008
Primary CompletionMay 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.1 years ago

Interventions

easypoddevice

Subjects is aware that the device records injection information that can be viewed by user

easypoddevice

Subjects is not aware that the device records injection information that can be viewed by user