Clinical trial NCT01112865: Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Deficiency
Keywords: Growth Hormone Deficiency
Somatropin
Injection Pen
Medical Device
Cross Over Study
Preference
Convenience
Children
Dyads
Adults
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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®
timeFrame: Month 4
Secondary outcomes:
measure: Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®
timeFrame: Month 4
measure: Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®
timeFrame: Month 4
measure: Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®
timeFrame: Month 4
measure: Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen
timeFrame: Month 4
measure: Ease of Use of Each Injection Pen
timeFrame: Month 2 and Month 4
Other outcomes:
Locations:
city: Brno - mesto
country: Czech Republic
facility: Fakultni Nemocnice Brno
city: Olomouc
country: Czech Republic
facility: Fakultni nemocnice Olomouc
city: Praha 2
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 5
country: Czech Republic
facility: Fakultni nemocnice v Motole
city: Datteln
country: Germany
facility: Vestische Kinder- und Jugendklinik Datteln
city: Erlangen
country: Germany
facility: Universitaetsklinik fuer Kinder und Jugendliche
city: Frankfurt-Niederrad
country: Germany
facility: Praxis fuer paediatrische Endokrinologie
city: Gauting
country: Germany
facility: Privatpraxis
city: Oldenburg
country: Germany
facility: Privatpraxis
city: Den Haag
country: Netherlands
facility: Juliana Kinderziekenhuis / Endocrinologie
city: Rotterdam
country: Netherlands
facility: Sophia Kinderziekenhuis
city: Bratislava
country: Slovakia
facility: Detska fakultna nemonica s poliklinikou, II. Detska klinika
city: Lubochna
country: Slovakia
facility: Narodny endokrinologicky a diabetologicky ustav
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM)
city: Goteborg
country: Sweden
facility: Drottning Silvias barn- och ungdomssjukhus, SU/Ostra
city: Linkoping
country: Sweden
facility: Barn och Ungdomsmedicinkliniken
city: Umea
country: Sweden
facility: Barnmedicinkliniken N
city: Sihhiye
country: Turkey
facility: Ankara University Medical Faculty Department of Internal Diseases
state: Ankara
city: Capa
country: Turkey
facility: Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases
state: Istanbul
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust, Hope Hospital
state: Manchester
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
city: London
country: United Kingdom
facility: St Thomas Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.