A6281297-CHOOSE Study, version number Amended Protocol 20 April 2010
Research type
Research Study
Full 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
IRAS ID
53386
Contact name
Tara Kearney
Sponsor organisation
Pfizer Limited,Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Eudract number
2009-017354-12
Clinicaltrials.gov Identifier
Research summary
Genotropin© is a human growth hormone (hGH) used to treat pediatric growth hormone deficiency and other forms of growth disturbance in children, and growth hormone deficiency in adults. It is administered by subcutaneous injection. For these daily injections the Genotropin Pen© can be used by patients. Recently a new injection pen, called the Genotropin Mark VII, has been developed to be used by patients. It is a disposable, multi-dose pen that can simplify the process of daily Genotropin administration and potentially increase patient compliance. The purpose of this study is to use the Injection Pen Assessment Questionnaire(IPAQ)to ask patients opinion as to which pen, the current Genotropin Pen© or the new Genotropin Mark VII pen they prefer and find easier to use. The IPAQ consists of two sections with Section I assessing the individual pen use and Section II comparing the current Genotropin Pen© and new Genotropin Mark VII pen. Paediatric and Adult patients age = 4 years, male or female starting treatment with growth hormone (Genotropin) for the first time. The study will recruit between a minimum of one hundred and a maximum of one hundred and thirty dyads(patient and caregiver)or adult patients. The numbers of Paediatric subjects to adults subjects will be approx 4:1 globally which reflects the numbers treated in clinical practice.
REC name
North West - Haydock Research Ethics Committee
REC reference
10/H1010/48
Date of REC Opinion
8 Nov 2010
REC opinion
Further Information Favourable Opinion