Easypod United States User Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Growth Hormone Deficiency

Intervention / Treatment
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* Device: easypod
* Device: easypod


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 - Log Aware<br>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. | Device: easypod<br>* Subjects is aware that the device records injection information that can be viewed by user<br>|
| Active Comparator: 2 - Log Unaware<br>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. | Device: easypod<br>* Subjects is not aware that the device records injection information that can be viewed by user<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log) |  | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |