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

Growth Hormone Deficiency Clinical Trial

— CHOOSE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112865
• Other study ID #: A6281297
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2010
• Last updated: May 15, 2012
• Start date: August 2010
• Est. completion date: October 2011

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Czech Republic	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
Germany	Vestische Kinder- und Jugendklinik Datteln	Datteln
Germany	Universitaetsklinik fuer Kinder und Jugendliche	Erlangen
Germany	Praxis fuer paediatrische Endokrinologie	Frankfurt-Niederrad
Germany	Privatpraxis	Gauting
Germany	Privatpraxis	Oldenburg
Netherlands	Juliana Kinderziekenhuis / Endocrinologie	Den Haag
Netherlands	Sophia Kinderziekenhuis	Rotterdam
Slovakia	Detska fakultna nemonica s poliklinikou, II. Detska klinika	Bratislava
Slovakia	Narodny endokrinologicky a diabetologicky ustav	Lubochna
Sweden	Drottning Silvias barn- och ungdomssjukhus, SU/Ostra	Goteborg
Sweden	Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM)	Goteborg
Sweden	Barn och Ungdomsmedicinkliniken	Linkoping
Sweden	Barnmedicinkliniken N	Umea
Turkey	Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases	Capa	Istanbul
Turkey	Ankara University Medical Faculty Department of Internal Diseases	Sihhiye	Ankara
United Kingdom	Royal Hospital for Sick Children	Glasgow
United Kingdom	St Thomas Hospital	London
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United Kingdom	Salford Royal NHS Foundation Trust, Hope Hospital	Salford	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Czech Republic,  Germany,  Netherlands,  Slovakia,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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