Status:
COMPLETED
Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Growth Hormone Deficiency
Eligibility:
MALE
7-17 years
Phase:
PHASE4
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...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00990340
Start Date
September 1 2009
End Date
August 1 2010
Last Update
July 25 2011
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