Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults
Andreas M Pleil,1 Feyza Darendeliler,2 Helmuth G Dörr,3 Katherine Hutchinson,4 Hartmut A Wollmann5 1Pfizer Inc., San Diego, CA, USA; 2Istanbul Faculty of Medicine, Pediatric Endocrinology Unit, Capa, Istanbul, Turkey; 3Department of Pediatrics, University of Erlangen, Erlangen, Germany; 4Q...
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Dove Medical Press
2014
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oai:doaj.org-article:e63a0ea8940446f5b99d577e65a389842021-12-02T06:21:04ZResults from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults1179-1470https://doaj.org/article/e63a0ea8940446f5b99d577e65a389842014-04-01T00:00:00Zhttp://www.dovepress.com/results-from-an-international-multicenter-trial-evaluating-the-ease-of-a16461https://doaj.org/toc/1179-1470 Andreas M Pleil,1 Feyza Darendeliler,2 Helmuth G Dörr,3 Katherine Hutchinson,4 Hartmut A Wollmann5 1Pfizer Inc., San Diego, CA, USA; 2Istanbul Faculty of Medicine, Pediatric Endocrinology Unit, Capa, Istanbul, Turkey; 3Department of Pediatrics, University of Erlangen, Erlangen, Germany; 4Quanticate, Hitchin, UK; 5Pfizer Ltd, Walton Oaks, UK Abstract: Previous research has reported that ease of use of and preference for a delivery device are associated with greater patient compliance – an important factor in achieving optimal therapeutic results. The objective of this study was to assess the ease-of-use of a new disposable pen (GoQuick®, Pfizer, Inc.) versus the current reusable pen (GENOTROPIN Pen®, Pfizer, Inc.) to inject a daily dose of recombinant DNA origin human growth hormone, Genotropin® (somatropin) in standard practice. In this randomized, crossover, multicenter, multinational, open-label study, ease-of-use of and preference for the two pens were assessed in three treatment-naïve populations: 1) parents of very young children; 2) parent–child dyads; and 3) adults via use of a validated self-report Injection Pen Assessment Questionnaire (IPAQ) after 2 months of at-home-use experience. The primary endpoint was the proportion of participants who reported the new disposable pen to be no different from or easier to use than the current reusable pen. Safety was also assessed and reported according to local legal requirements. Of the 120 screened patients, 119 were included in the ease-of-use analysis and all were included in the safety analyses. In all, 67.2% found the new somatropin disposable pen to be no different from or easier to use than the reusable pen (95% confidence interval: 58.8–75.7). Most adverse events were mild or moderate. No deaths or device- or treatment-related serious adverse events were reported. These results suggest that improvements made to the reusable somatropin pen are tangible and recognizable to treatment-naïve patients and their caregivers, child–caregiver dyads, and adults, and may positively impact continued compliance with therapy. Registry information: ClinicalTrials.gov identifier: NCT01112865. Keywords: somatropin, disposable injection pen, ease-of-use, Injection Pen Assessment Questionnaire, preference, recombinant human growth hormonePleil AMDarendeliler FDörr HGHutchinson KWollmann HADove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2014, Iss default, Pp 61-71 (2014) |
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Medical technology R855-855.5 Pleil AM Darendeliler F Dörr HG Hutchinson K Wollmann HA Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults |
| description |
Andreas M Pleil,1 Feyza Darendeliler,2 Helmuth G Dörr,3 Katherine Hutchinson,4 Hartmut A Wollmann5 1Pfizer Inc., San Diego, CA, USA; 2Istanbul Faculty of Medicine, Pediatric Endocrinology Unit, Capa, Istanbul, Turkey; 3Department of Pediatrics, University of Erlangen, Erlangen, Germany; 4Quanticate, Hitchin, UK; 5Pfizer Ltd, Walton Oaks, UK Abstract: Previous research has reported that ease of use of and preference for a delivery device are associated with greater patient compliance – an important factor in achieving optimal therapeutic results. The objective of this study was to assess the ease-of-use of a new disposable pen (GoQuick®, Pfizer, Inc.) versus the current reusable pen (GENOTROPIN Pen®, Pfizer, Inc.) to inject a daily dose of recombinant DNA origin human growth hormone, Genotropin® (somatropin) in standard practice. In this randomized, crossover, multicenter, multinational, open-label study, ease-of-use of and preference for the two pens were assessed in three treatment-naïve populations: 1) parents of very young children; 2) parent–child dyads; and 3) adults via use of a validated self-report Injection Pen Assessment Questionnaire (IPAQ) after 2 months of at-home-use experience. The primary endpoint was the proportion of participants who reported the new disposable pen to be no different from or easier to use than the current reusable pen. Safety was also assessed and reported according to local legal requirements. Of the 120 screened patients, 119 were included in the ease-of-use analysis and all were included in the safety analyses. In all, 67.2% found the new somatropin disposable pen to be no different from or easier to use than the reusable pen (95% confidence interval: 58.8–75.7). Most adverse events were mild or moderate. No deaths or device- or treatment-related serious adverse events were reported. These results suggest that improvements made to the reusable somatropin pen are tangible and recognizable to treatment-naïve patients and their caregivers, child–caregiver dyads, and adults, and may positively impact continued compliance with therapy. Registry information: ClinicalTrials.gov identifier: NCT01112865. Keywords: somatropin, disposable injection pen, ease-of-use, Injection Pen Assessment Questionnaire, preference, recombinant human growth hormone |
| format |
article |
| author |
Pleil AM Darendeliler F Dörr HG Hutchinson K Wollmann HA |
| author_facet |
Pleil AM Darendeliler F Dörr HG Hutchinson K Wollmann HA |
| author_sort |
Pleil AM |
| title |
Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults |
| title_short |
Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults |
| title_full |
Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults |
| title_fullStr |
Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults |
| title_full_unstemmed |
Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults |
| title_sort |
results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults |
| publisher |
Dove Medical Press |
| publishDate |
2014 |
| url |
https://doaj.org/article/e63a0ea8940446f5b99d577e65a38984 |
| work_keys_str_mv |
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