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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


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


Minimum age: 4 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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