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

Overview

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®)

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2010

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).

Interventions

  • Device: T-jet® containing TevTropin®
    • Needle-free delivery 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

Arms, Groups and Cohorts

  • Active Comparator: Tev-Tropin® needle-free
    • needle-free injection method (T-jet®)for 14 days before cross-over to other arm
  • Active Comparator: Tev-Tropin® by Needle-syringe
    • needle-syringe injection method for 14 days before cross-over to other arm

Clinical Trial Outcome Measures

Primary Measures

  • Subject-reported Injection Anxiety Immediately Before Administration
    • Time Frame: 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 Measures

  • Subject-reported Injection Pain Immediately Following Administration.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 7 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Teva Branded Pharmaceutical Products R&D, Inc.
  • Provider of Information About this Clinical Study
    • Iris Culbert; Clinical Trials Manager, Teva Neuroscience
  • Overall Official(s)
    • Thomas Smith, MD, Study Director, Teva Pharmaceutical Industries, Ltd.

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