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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

2014-08-27 03:18:52 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:52-0400

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Medical and Biotech [MESH] Definitions

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.

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.

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.

Introduction of substances into the body using a needle and syringe.

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.

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