Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Intervention: T-jet® containing TevTropin®; TevTropin® needle-syringe injection method
Intervention description: Needle-free delivery method for 14 days before cross-over to other arm; comparison of delivery methods for 14 days before cross-over to other arm
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Male
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No

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®)
    

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