Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects

Study Overview
=================
Brief Summary
-----------------
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.

Official Title
-----------------
A Multicenter, Open-label, Randomized Two Arm Cross Over Study Assessing Dyad (Subject and Caregiver) and Adult Subject Perception of Convenience and Preference of the Newly Developed Genotropin Mark VII Pen.

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Device: Genotropin Pen
* Device: MARK VII pen
* Device: Genotropin Pen
* Device: MARK VII pen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 8 years. Subjects who are starting treatment with growth hormone (Genotropin) for the first time. Exclusion Criteria: Subjects with Prader-Willi syndrome or chronic renal insufficiency. Subjects and caregivers who, in the opinion of the investigator are not able to adequately participate in the study. Subjects with chronic systemic disorders, such as diabetes and heart disease.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mark VII/Current pen<br>Subject will use Mark VII pen for 2 months followed by Current pen for 2 months | Device: Genotropin Pen<br>* Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.<br>Device: MARK VII pen<br>* Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.<br>|
| Other: Current pen/Mark VII<br>Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months | Device: Genotropin Pen<br>* Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.<br>Device: MARK VII pen<br>* Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall? Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference. | Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall. Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference. | Month 4 | 
| Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall? Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference. | Month 4 | 
| Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall. Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference. | Month 4 | 
| Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen | Investigators were asked the following study treatment continuation question, Which device did the participant choose for continued treatment? Choices included the Genotropin® Pen or the new injection pen. | Month 4 | 
| Ease of Use of Each Injection Pen | Participants were asked the following question from Section I of the IPAQ PRO tool, Thinking about the injection pen you have been using for the past few months, how easy or difficult it is for you to use the injection pen overall? Responses were provided using a 5 point scale which ranged from very easy (5), somewhat easy (4), neither easy nor difficult (3), somewhat difficult (2), or very difficult (1). | Month 2 and Month 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyads, Growth Hormone Deficiency, Somatropin, Injection Pen, Medical Device, Cross Over Study, Preference, Convenience, Children, Adults