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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01112865
First received: April 20, 2010
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Growth Hormone Deficiency
Device: Genotropin Pen
Device: MARK VII pen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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® [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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:
  • Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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® [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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® [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 2 and Month 4 ] [ Designated as safety issue: No ]
    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).


Enrollment: 120
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 12mg 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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112865

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01112865     History of Changes
Other Study ID Numbers: A6281297
Study First Received: April 20, 2010
Results First Received: April 16, 2012
Last Updated: May 15, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Pfizer:
Growth Hormone Deficiency
Somatropin
Injection Pen
Medical Device
Cross Over Study
Preference
Convenience
Children
Dyads
Adults

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 26, 2014