Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain psychological response and user preference information on the use of the T jet® device versus the traditional subcutaneous injection administration of Tev Tropin®. This study will compare subject-reported injection anxiety immediately before the administration of each dose of Tev-Tropin® between a needle-syringe injection method and a needle-free injection method (T-jet®)

Detailed Description
-----------------
The primary efficacy endpoint was the difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5-point FIS immediately before administration. A higher score denoted greater anxiety. The injection anxiety score was to be reported by the subject from a row of five faces with values ranging from 5 (the face with the most negative affect) to 1 (the face with the most positive affect).

Official Title
-----------------
Study to Compare Injection Anxiety Immediately Before the Administration of Each Dose of Tev-Tropin® Between a Needle-syringe Injection Method and a Needle-free Injection Method in Pediatric Subjects With Human Growth Hormone Deficiency

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

Intervention / Treatment
-----------------
* Device: T-jet® containing TevTropin®
* Procedure: TevTropin® needle-syringe injection method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must require a routine Tev-Tropin® dose that does not exceed 2.5 mg in one injection (0.5 mL) using the dosing schedule individualized for each patient by their prescribing physician Male, age 7-17 years, with the capability to provide assent, as determined by the investigator and/or parent or legal guardian Clinically definite growth hormone deficiency as previously diagnosed by the investigator or other physician Subjects must be using Tev-Tropin® prior to enrollment for 28 days Informed consent signed by parent(s) or legal custodian of patient prior to study entry and patient assent as determined by the investigator and/or subject's parent or legal custodian Exclusion Criteria: More than one subcutaneous injection per Tev-Tropin® dose Female gender Use of any other needle-free injection device at any time Current use of another human growth hormone product other than Tev-Tropin® Concurrent treatment with other routine injectable medications History of benign intracranial hypertension Significant communication difficulties, or medical or psychiatric condition, that affects the subject's and/or caregiver's ability to perform the necessary functions to complete the study, or any condition which the investigator in their medical judgment thinks may interfere with participation in the study Use of an investigational drug within 30 days prior to randomization Contraindications related to routine use of Tev-Tropin® as per investigators' medical judgment (e.g., subjects with closed epiphyses, active proliferative or severe non-proliferative diabetic retinopathy, active malignancy, acute critical illness, or Prader-Willi syndrome who are severely obese or have severe respiratory impairment) Current participation in another pharmaceutical or device study Previous participation in this study

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Active Comparator: Tev-Tropin® needle-free<br>needle-free injection method (T-jet®)for 14 days before cross-over to other arm | Device: T-jet® containing TevTropin®<br>* Needle-free delivery method for 14 days before cross-over to other arm<br>* Other names: T-jet®;|
| Active Comparator: Tev-Tropin® by Needle-syringe<br>needle-syringe injection method for 14 days before cross-over to other arm | Procedure: TevTropin® needle-syringe injection method<br>* comparison of delivery methods for 14 days before cross-over to other arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-reported Injection Anxiety Immediately Before Administration | The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study. | 28 days; Period 1: 14 days, Period 2: 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-reported Injection Pain Immediately Following Administration. | The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study. | 28 days; Period 1: 14 days, Period 2: 14 days | 
| Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale. | The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like arms were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study. | 2 weeks | 
| Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale. | The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary. | 28 Days; end of Period 1(14 days) and end of Period 2 (14 days) | 
| Subject-reported Overall Satisfaction Following the End of Each Period of the Study. | The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary. | 28 Days; end of Period 1(14 days) and end of Period 2 (14 days) |