Easypod United States User Trial

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Be male or female from 10 to 18 years of age, inclusive, with open epiphyses
Have GH deficiency diagnosed by treating pediatric endocrinologist for at least 6 months
Be undergoing rhGH treatment via self-injection using the Lilly Humatrope® or Pfizer Genotropin® pen injection device for at least 6 months
Be willing and able to comply with the protocol for the duration of the trial
Have access to the Internet
Be able to read, speak and understand English
If female of childbearing potential, have a negative urine pregnancy test at Screening and use an acceptable form of birth control during the trial, including abstinence, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide

Exclusion Criteria

Known allergy or hypersensitivity to rhGH or prescribed diluent (0.3% metacresol for click.easy® cartridge)
Severe illness during the previous 6 months
Active malignancy (except non-melanomatous skin malignancies)
Diabetes mellitus (type I or II)
Pregnancy or lactation
Any medical condition that, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to the investigational device
Participation in any other investigational study during the duration of participation in this trial

Arm && Interventions

Group	Intervention	Description
1 - Log Aware	easypod	Dose Log Aware (patient is aware that the device records their injection information) Half the subjects in the log aware arm will complete a diary. The other half in the log aware arm will not complete the diary.
2 - Log Unaware	easypod	Dose Log Unaware (patient is not aware that the device records their injection information) Half the subjects in the log unaware arm will complete a diary. The other half in the log unaware arm will not complete the diary.

Primary Outcome Measures

Name	Time	Method
Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)	90 Days

Secondary Outcome Measures

Name	Time	Method
Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices	90 Days
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.	90 Days
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.	90 Days