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

Phase 4

Completed

Conditions: Growth Hormone Deficiency

Interventions: Device: T-jet® containing TevTropin®
Procedure: TevTropin® needle-syringe injection method

Registration Number: NCT00990340

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 52

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tev-Tropin® needle-free	T-jet® containing TevTropin®	needle-free injection method (T-jet®)for 14 days before cross-over to other arm
Tev-Tropin® by Needle-syringe	TevTropin® needle-syringe injection method	needle-syringe injection method for 14 days before cross-over to other arm

Primary Outcome Measures

Name	Time	Method
Subject-reported Injection Anxiety Immediately Before Administration	28 days; Period 1: 14 days, Period 2: 14 days	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.

Secondary Outcome Measures

Name	Time	Method
Subject-reported Injection Pain Immediately Following Administration.	28 days; Period 1: 14 days, Period 2: 14 days	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.
Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.	2 weeks	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.
Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.	28 Days; end of Period 1(14 days) and end of Period 2 (14 days)	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.
Subject-reported Overall Satisfaction Following the End of Each Period of the Study.	28 Days; end of Period 1(14 days) and end of Period 2 (14 days)	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.