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

A Multicenter, Open-label, Randomized Two Arm Cross Over Study Assessing Dyad (Subject and Caregiver) and Adult Subject Perception of Convenience and Preference of the Newly Developed Genotropin Mark VII Pen.

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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Deficiency
• Intervention / Treatment: Device: Genotropin Pen; Device: MARK VII pen; Device: Genotropin Pen

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • Brno - mesto, Czech Republic, 61300
    • Fakultní nemocnice Brno
  • Olomouc, Czech Republic, 775 20
    • Fakultni Nemocnice Olomouc
  • Praha 2, Czech Republic, 128 08
    • Všeobecná fakultní nemocnice v Praze
  • Praha 5, Czech Republic, 150 06
    • Fakultni nemocnice v Motole
• Germany
  • Datteln, Germany, 45711
    • Vestische Kinder- und Jugendklinik Datteln
  • Erlangen, Germany, 91054
    • Universitaetsklinik fuer Kinder und Jugendliche
  • Frankfurt-Niederrad, Germany, 60528
    • Praxis fuer paediatrische Endokrinologie
  • Gauting, Germany, 82131
    • Privatpraxis
  • Oldenburg, Germany, 26122
    • Privatpraxis
• Netherlands
  • Den Haag, Netherlands
    • Juliana Kinderziekenhuis / Endocrinologie
  • Rotterdam, Netherlands, 3015 GD
    • Sophia Kinderziekenhuis
• Slovakia
  • Bratislava, Slovakia, 833 40
    • Detska fakultna nemonica s poliklinikou, II. Detska klinika
  • Lubochna, Slovakia, 034 91
    • Narodny Endokrinologicky a diabetologicky ustav
• Sweden
  • Goteborg, Sweden, 413 45
    • Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM)
  • Goteborg, Sweden, 416 85
    • Drottning Silvias barn- och ungdomssjukhus, SU/Ostra
  • Linkoping, Sweden, 581 85
    • Barn och Ungdomsmedicinkliniken
  • Umea, Sweden, 901 85
    • Barnmedicinkliniken N
• Turkey
  • Ankara
    • Sihhiye, Ankara, Turkey, 06100
      • Ankara University Medical Faculty Department of Internal Diseases
  • Istanbul
    • Capa, Istanbul, Turkey, 34390
      • Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases
• United Kingdom
  • Glasgow, United Kingdom, G3 8SJ
    • Royal Hospital for Sick Children
  • London, United Kingdom, SE1 7EH
    • St Thomas Hospital
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospital
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Salford Royal NHS Foundation Trust, Hope Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Mark VII/Current pen; Subject will use Mark VII pen for 2 months followed by Current pen for 2 months	Device: Genotropin Pen; Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.; Device: MARK VII pen; Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.; Device: Genotropin Pen; Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
OTHER: Current pen/Mark VII; Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months	Device: Genotropin Pen; Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.; Device: MARK VII pen; Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.; Device: Genotropin Pen; Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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®	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.	Month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®	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.	Month 4
Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®	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.	Month 4
Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®	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.	Month 4
Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen	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.	Month 4
Ease of Use of Each Injection Pen	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).	Month 2 and Month 4

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Pleil AM, Darendeliler F, Dorr 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-naive children and adults. Med Devices (Auckl). 2014 Apr 11;7:61-71. doi: 10.2147/MDER.S59821. eCollection 2014.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: April 27, 2010
• First Posted (ESTIMATE): April 28, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 22, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Children; Adults; Growth Hormone Deficiency; Medical Device; Somatropin; Preference; Dyads; Injection Pen; Cross Over Study; Convenience
• Other Study ID Numbers: A6281297