Comparison of a Needle-free Injection Method (T-jet™) With a Needle-syringe Injection Method for the Delivery of Tev-Tropin® in Pediatric Subjects With Human Growth Hormone Deficiency
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™)
Study Design
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Growth Hormone Deficiency
Intervention
T-jet™, needle-syringe injection method
Location
University of Alabama at Birmingham
Birmingham
Alabama
United States
35206
Status
Active, not recruiting
Source
Teva Pharmaceutical Industries
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00990340
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Dwarfism, Pituitary
A form of dwarfism caused by complete or partial GROWTH HORMONE deficiency, resulting from either the lack of GROWTH HORMONE-RELEASING FACTOR from the HYPOTHALAMUS or from the mutations in the growth hormone gene (GH1) in the PITUITARY GLAND. It is also known as Type I pituitary dwarfism. Human hypophysial dwarf is caused by a deficiency of HUMAN GROWTH HORMONE during development.
Human Growth Hormone
A 191-amino acid polypeptide hormone secreted by the human adenohypophysis (PITUITARY GLAND, ANTERIOR), also known as GH or somatotropin. Synthetic growth hormone, termed somatropin, has replaced the natural form in therapeutic usage such as treatment of dwarfism in children with growth hormone deficiency.
Laron Syndrome
An autosomal recessive disorder characterized by short stature, defective GROWTH HORMONE RECEPTOR, and failure to generate INSULIN-LIKE GROWTH FACTOR I by GROWTH HORMONE. Laron syndrome is not a form of primary pituitary dwarfism (GROWTH HORMONE DEFICIENCY DWARFISM) but the result of mutation of the human GHR gene on chromosome 5.
Sermorelin
The biologically active fragment of human growth hormone-releasing factor, consisting of GHRH(1-29)-amide. This N-terminal sequence is identical in several mammalian species, such as human, pig, and cattle. It is used to diagnose or treat patients with GROWTH HORMONE deficiency.
Growth Hormone-secreting Pituitary Adenoma
A pituitary tumor that secretes GROWTH HORMONE. In humans, excess HUMAN GROWTH HORMONE leads to ACROMEGALY.
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PubMed Articles
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Growth hormone replacement unequivocally benefits growth, body composition, cardiovascular risk factors and quality of life. Less is known about the effects of growth hormone on learning and memory. T...
Progression of Chiari I malformations while on growth hormone replacement: a report of two cases.
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Estimating the cost-effectiveness of needle-syringe programs in Australia.
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ABSTRACT: INTRODUCTION: Adult Growth hormone Deficiency is a well known phenomenon effecting both males and females. Adult Growth Hormone Deficiency is marked by a number of neuropsychiatric, cognitiv...
