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- Title
Are Needle-Free Injections a Useful Alternative for Growth Hormone Therapy in Children? Safety and Pharmacokinetics of Growth Hormone Delivered by a New Needle-Free Injection Device Compared to a Fine Gauge Needle.
- Authors
Dörr, H. G.; Zabransky, S.; Keller, E.; Otten, B. J.; Partsch, C. -J.; Nyman, L.; Gillespie, B. K.; Lester, N. R.; Wilson, A. M.; Hyren, Cecilia; van Kuijck, M. A.; Schuld, P.; Schoenfeld, S. L.
- Abstract
The clinical safety, use and pharmacokinetics of a new needle-free device for delivery of growth hormone (GH) were compared with those of conventional needle injection devices. In an open-label, randomized, 4-period crossover study, 18 healthy adults received single subcutaneous injections of Genotropin® administered by the Genotropin ZipTip™ needle-free device and by conventional injection. Bioequivalence was established between the devices. In a separate open-label, randomized, multicenter, 2-period crossover study, pediatric patients underwent 2-weeks Genotropin® treatment administered by the Genotropin ZipTip™ and by a fine-gauge needle device (>95% used the Genotropin Pen®). In total, 128/133 patients who were treated completed the study. Genotropin ZipTip™ was well tolerated and >50% of patients found no difference between the devices for all parameters assessed. After study completion, >20% patients preferred to continue using Genotropin ZipTip™. Although statistical analyses demonstrated superiority of the Genotropin Pen® versus Genotropin ZipTip™ for bleeding, pain, soreness, and bruising, Genotropin ZipTip™ was considered to provide a safe and bioequivalent alternative to needle injection.
- Publication
Journal of Pediatric Endocrinology & Metabolism, 2003, Vol 16, Issue 3, p383
- ISSN
0334-018X
- Publication type
Article
- DOI
10.1515/jpem.2003.16.3.383