Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects

Phase 3

Completed

• Conditions: Growth Hormone Deficiency

• 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

Study Timeline

• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Study Start: 2010-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-04-16
• Results First Submitted QC: 2012-04-16
• Status Verified: 2012-05
• Results First Posted: 2012-05-14
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age greater than or equal to 8 years.
• Subjects who are starting treatment with growth hormone (Genotropin) for the first time.

Exclusion Criteria

• 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

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)

Fakultni Nemocnice Brno; 🇨🇿 Brno - mesto, Czech Republic

Fakultni nemocnice Olomouc; 🇨🇿 Olomouc, Czech Republic

Vseobecna fakultni nemocnice v Praze; 🇨🇿 Praha 2, Czech Republic

Fakultni nemocnice v Motole; 🇨🇿 Praha 5, Czech Republic

Vestische Kinder- und Jugendklinik Datteln; 🇩🇪 Datteln, Germany

Universitaetsklinik fuer Kinder und Jugendliche; 🇩🇪 Erlangen, Germany

Praxis fuer paediatrische Endokrinologie; 🇩🇪 Frankfurt-Niederrad, Germany

Privatpraxis; 🇩🇪 Oldenburg, Germany

Juliana Kinderziekenhuis / Endocrinologie; 🇳🇱 Den Haag, Netherlands

Sophia Kinderziekenhuis; 🇳🇱 Rotterdam, Netherlands

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