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.
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.
authors.affiliation: Department of Paediatric Endocrinology, University Erlangen-Nurnberg, Erlangen, Germany.
authors.forename: H G
authors.initials: HG
authors.lastname: Dörr
authors.forename: S
authors.initials: S
authors.lastname: Zabransky
authors.forename: E
authors.initials: E
authors.lastname: Keller
authors.forename: B J
authors.initials: BJ
authors.lastname: Otten
authors.forename: C J
authors.initials: CJ
authors.lastname: Partsch
authors.forename: L
authors.initials: L
authors.lastname: Nyman
authors.forename: B K
authors.initials: BK
authors.lastname: Gillespie
authors.forename: N R
authors.initials: NR
authors.lastname: Lester
authors.forename: A M
authors.initials: AM
authors.lastname: Wilson
authors.forename: Cecilia
authors.initials: C
authors.lastname: Hyrén
authors.forename: M A
authors.initials: MA
authors.lastname: van Kuijck
authors.forename: P
authors.initials: P
authors.lastname: Schuld
authors.forename: S L
authors.initials: SL
authors.lastname: Schoenfeld
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D003288:Contusions / Q000209:etiology / Q000517:prevention & control; D018592:Cross-Over Studies; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D006801:Humans; D007277:Injections, Jet / Q000009:adverse effects* / Q000295:instrumentation; D007279:Injections, Subcutaneous / Q000009:adverse effects / Q000295:instrumentation*; D008297:Male; D010342:Patient Acceptance of Health Care; D012016:Reference Values; D013810:Therapeutic Equivalency
chemical_list: D019382:Human Growth Hormone