Phase 4
Completed N=52
Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
Source: ClinicalTrials.gov NCT00990340 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: Subject-reported Injection Anxiety Immediately Before Administration — 2.15; 1.98 Scores on a scale
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®)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject-reported Injection Anxiety Immediately Before Administration |
2.15; 1.98 | — |
| SECONDARY Subject-reported Injection Pain Immediately Following Administration. |
0.96; 0.89 | — |
| SECONDARY Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale. |
2.55; 1.78 | — |
| SECONDARY Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale. |
2.40; 1.76 | — |
| SECONDARY Subject-reported Overall Satisfaction Following the End of Each Period of the Study. |
3.31; 3.96 | — |
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
Data sourced from ClinicalTrials.gov (NCT00990340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.