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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.
- Source :
-
Journal of pediatric endocrinology & metabolism : JPEM [J Pediatr Endocrinol Metab] 2003 Mar; Vol. 16 (3), pp. 383-92. - Publication Year :
- 2003
-
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.
- Subjects :
- Adolescent
Adult
Child
Child, Preschool
Contusions etiology
Contusions prevention & control
Cross-Over Studies
Female
Hemorrhage etiology
Hemorrhage prevention & control
Humans
Injections, Jet instrumentation
Injections, Subcutaneous adverse effects
Male
Patient Acceptance of Health Care
Reference Values
Therapeutic Equivalency
Human Growth Hormone administration & dosage
Human Growth Hormone pharmacokinetics
Injections, Jet adverse effects
Injections, Subcutaneous instrumentation
Subjects
Details
- Language :
- English
- ISSN :
- 0334-018X
- Volume :
- 16
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Journal of pediatric endocrinology & metabolism : JPEM
- Publication Type :
- Academic Journal
- Accession number :
- 12705363
- Full Text :
- https://doi.org/10.1515/jpem.2003.16.3.383