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

Primary Purpose

Growth Hormone Deficiency

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
T-jet® containing TevTropin®
TevTropin® needle-syringe injection method
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency

Eligibility Criteria

7 Years - 17 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Tev-Tropin® needle-free

    Tev-Tropin® by Needle-syringe

    Arm Description

    needle-free injection method (T-jet®)for 14 days before cross-over to other arm

    needle-syringe injection method for 14 days before cross-over to other arm

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    October 5, 2009
    Last Updated
    June 23, 2011
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00990340
    Brief Title
    Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
    Acronym
    T-jet®
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Growth Hormone Deficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tev-Tropin® needle-free
    Arm Type
    Active Comparator
    Arm Description
    needle-free injection method (T-jet®)for 14 days before cross-over to other arm
    Arm Title
    Tev-Tropin® by Needle-syringe
    Arm Type
    Active Comparator
    Arm Description
    needle-syringe injection method for 14 days before cross-over to other arm
    Intervention Type
    Device
    Intervention Name(s)
    T-jet® containing TevTropin®
    Other Intervention Name(s)
    T-jet®
    Intervention Description
    Needle-free delivery method for 14 days before cross-over to other arm
    Intervention Type
    Procedure
    Intervention Name(s)
    TevTropin® needle-syringe injection method
    Intervention Description
    comparison of delivery methods for 14 days before cross-over to other arm
    Primary Outcome Measure Information:
    Title
    Subject-reported Injection Anxiety Immediately Before Administration
    Description
    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.
    Time Frame
    28 days; Period 1: 14 days, Period 2: 14 days
    Secondary Outcome Measure Information:
    Title
    Subject-reported Injection Pain Immediately Following Administration.
    Description
    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.
    Time Frame
    28 days; Period 1: 14 days, Period 2: 14 days
    Title
    Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.
    Description
    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.
    Time Frame
    2 weeks
    Title
    Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.
    Description
    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.
    Time Frame
    28 Days; end of Period 1(14 days) and end of Period 2 (14 days)
    Title
    Subject-reported Overall Satisfaction Following the End of Each Period of the Study.
    Description
    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.
    Time Frame
    28 Days; end of Period 1(14 days) and end of Period 2 (14 days)

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Smith, MD
    Organizational Affiliation
    Teva Pharmaceutical Industries, Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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