Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
- Conditions
- Growth Hormone Deficiency
- Interventions
- Device: Genotropin PenDevice: MARK VII pen
- Registration Number
- NCT01112865
- Lead Sponsor
- Pfizer
- Brief Summary
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Age greater than or equal to 8 years.
- Subjects who are starting treatment with growth hormone (Genotropin) for the first time.
- Subjects with Prader-Willi syndrome or chronic renal insufficiency.
- Subjects and caregivers who, in the opinion of the investigator are not able to adequately participate in the study.
- Subjects with chronic systemic disorders, such as diabetes and heart disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Mark VII/Current pen Genotropin Pen Subject will use Mark VII pen for 2 months followed by Current pen for 2 months Mark VII/Current pen MARK VII pen Subject will use Mark VII pen for 2 months followed by Current pen for 2 months Current pen/Mark VII Genotropin Pen Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months Current pen/Mark VII MARK VII pen Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months
- Primary Outcome Measures
Name Time Method Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® Month 4 Participants were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference.
- Secondary Outcome Measures
Name Time Method Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® Month 4 Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall." Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference.
Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen® Month 4 Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference.
Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen® Month 4 Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall." Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference.
Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen Month 4 Investigators were asked the following study treatment continuation question, "Which device did the participant choose for continued treatment?" Choices included the Genotropin® Pen or the new injection pen.
Ease of Use of Each Injection Pen Month 2 and Month 4 Participants were asked the following question from Section I of the IPAQ PRO tool, "Thinking about the injection pen you have been using for the past few months, how easy or difficult it is for you to use the injection pen overall?" Responses were provided using a 5 point scale which ranged from very easy (5), somewhat easy (4), neither easy nor difficult (3), somewhat difficult (2), or very difficult (1).
Trial Locations
- Locations (22)
Barn och Ungdomsmedicinkliniken
🇸🇪Linkoping, Sweden
Salford Royal NHS Foundation Trust, Hope Hospital
🇬🇧Salford, Manchester, United Kingdom
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czech Republic
Universitaetsklinik fuer Kinder und Jugendliche
🇩🇪Erlangen, Germany
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czech Republic
Vestische Kinder- und Jugendklinik Datteln
🇩🇪Datteln, Germany
Juliana Kinderziekenhuis / Endocrinologie
🇳🇱Den Haag, Netherlands
Sophia Kinderziekenhuis
🇳🇱Rotterdam, Netherlands
Praxis fuer paediatrische Endokrinologie
🇩🇪Frankfurt-Niederrad, Germany
Privatpraxis
🇩🇪Oldenburg, Germany
Drottning Silvias barn- och ungdomssjukhus, SU/Ostra
🇸🇪Goteborg, Sweden
Narodny endokrinologicky a diabetologicky ustav
🇸🇰Lubochna, Slovakia
Detska fakultna nemonica s poliklinikou, II. Detska klinika
🇸🇰Bratislava, Slovakia
Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM)
🇸🇪Goteborg, Sweden
Ankara University Medical Faculty Department of Internal Diseases
🇹🇷Sihhiye, Ankara, Turkey
Barnmedicinkliniken N
🇸🇪Umea, Sweden
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases
🇹🇷Capa, Istanbul, Turkey
Royal Hospital for Sick Children
🇬🇧Glasgow, United Kingdom
St Thomas Hospital
🇬🇧London, United Kingdom
Fakultni Nemocnice Brno
🇨🇿Brno - mesto, Czech Republic