Clinical trial NCT00990340: Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Growth Hormone Deficiency
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-06
Enrollment: 52
Sex: MALE
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Subject-reported Injection Anxiety Immediately Before Administration
timeFrame: 28 days; Period 1: 14 days, Period 2: 14 days
Secondary outcomes:
measure: Subject-reported Injection Pain Immediately Following Administration.
timeFrame: 28 days; Period 1: 14 days, Period 2: 14 days
measure: Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.
timeFrame: 2 weeks
measure: Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.
timeFrame: 28 Days; end of Period 1(14 days) and end of Period 2 (14 days)
measure: Subject-reported Overall Satisfaction Following the End of Each Period of the Study.
timeFrame: 28 Days; end of Period 1(14 days) and end of Period 2 (14 days)
Other outcomes:
Locations:
Study officials:
affiliation: Teva Pharmaceutical Industries, Ltd.
name: Thomas Smith, MD
role: STUDY_DIRECTOR
References: