Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: Genotropin Pen (Device); MARK VII pen (Device); Genotropin Pen (Device); MARK VII pen (Device)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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®
Secondary outcome: Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen® Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen® Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen Ease of Use of Each Injection Pen
Eligibility
Minimum age: 4 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Fakultni Nemocnice Brno, Brno - mesto 61300, Czech Republic
Fakultni nemocnice Olomouc, Olomouc 775 20, Czech Republic
Vseobecna fakultni nemocnice v Praze, Praha 2 128 08, Czech Republic
Fakultni nemocnice v Motole, Praha 5 150 06, Czech Republic
Vestische Kinder- und Jugendklinik Datteln, Datteln 45711, Germany
Universitaetsklinik fuer Kinder und Jugendliche, Erlangen 91054, Germany
Praxis fuer paediatrische Endokrinologie, Frankfurt-Niederrad 60528, Germany
Privatpraxis, Gauting 82131, Germany
Privatpraxis, Oldenburg 26122, Germany
Juliana Kinderziekenhuis / Endocrinologie, Den Haag, Netherlands
Sophia Kinderziekenhuis, Rotterdam 3015 GD, Netherlands
Detska fakultna nemonica s poliklinikou, II. Detska klinika, Bratislava 833 40, Slovakia
Narodny endokrinologicky a diabetologicky ustav, Lubochna 034 91, Slovakia
Drottning Silvias barn- och ungdomssjukhus, SU/Ostra, Goteborg 416 85, Sweden
Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM), Goteborg 413 45, Sweden
Barn och Ungdomsmedicinkliniken, Linkoping 581 85, Sweden
Barnmedicinkliniken N, Umea 901 85, Sweden
Royal Hospital for Sick Children, Glasgow G3 8SJ, United Kingdom
St Thomas Hospital, London SE1 7EH, United Kingdom
Norfolk and Norwich University Hospital, Norwich NR4 7UY, United Kingdom
Ankara University Medical Faculty Department of Internal Diseases, Sihhiye, Ankara 06100, Turkey
Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases, Capa, Istanbul 34390, Turkey
Salford Royal NHS Foundation Trust, Hope Hospital, Salford, Manchester M6 8HD, United Kingdom
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: August 2010
Last updated: May 15, 2012
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