Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method (T-jet®)

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

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®)

Study Overview

• Status: Completed
• Conditions: Growth Hormone Deficiency
• Intervention / Treatment: Device: T-jet® containing TevTropin®; Procedure: TevTropin® needle-syringe injection method

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).

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tev-Tropin® needle-free; needle-free injection method (T-jet®)for 14 days before cross-over to other arm	Device: T-jet® containing TevTropin®; Needle-free delivery method for 14 days before cross-over to other arm; Other Names: T-jet®
Active Comparator: Tev-Tropin® by Needle-syringe; needle-syringe injection method for 14 days before cross-over to other arm	Procedure: TevTropin® needle-syringe injection method; comparison of delivery methods for 14 days before cross-over to other arm

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)

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Thomas Smith, MD, Teva Pharmaceutical Industries, Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: October 5, 2009
• First Submitted That Met QC Criteria: October 5, 2009
• First Posted (Estimate): October 6, 2009

Study Record Updates

• Last Update Posted (Estimate): July 25, 2011
• Last Update Submitted That Met QC Criteria: June 23, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary
• Other Study ID Numbers: PM201