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

Teva Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Growth Hormone Deficiency

Treatments

Device: T-jet® containing TevTropin®

Procedure: TevTropin® needle-syringe injection method

Study type

Interventional

Funder types

Industry

Identifiers

NCT00990340

PM201

Details and patient eligibility

About

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 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).

Enrollment

52 patients

Sex

Male

Ages

7 to 17 years old

Volunteers

No 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