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

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).

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