C0311002
Research type
Research Study
Full title
A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY
IRAS ID
253770
Contact name
Mehul Dattani
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2018-000918-38
Duration of Study in the UK
0 years, 11 months, 24 days
Research summary
The purpose of this study is to evaluate the treatment experience of a weekly somatrogon injection schedule and a daily Genotropin® injection schedule. The study is being conducted at approximately 25 different research sites in up to 6 countries; approximately 90 subjects, who have either isolated Growth Hormone Deficiency (GHD) or Growth Hormone insufficiency, will be enrolled. The planned study duration is 24 weeks with a screening period of up to 30 days and a follow-up phone call four weeks after the last clinic visit. Subjects will be randomized to one of two sequences, either 12 weeks of continued treatment with daily Genotropin® followed by 12 weeks of treatment with weekly somatrogon, or 12 weeks of treatment with weekly somatrogon followed by 12 weeks of treatment with daily Genotropin®. Subjects and caregivers will complete questionnaires at the beginning and end of each 12 week treatment period. After completion of the study, subjects will return to their previous treatment with Genotropin® unless directed otherwise by their doctor.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0122
Date of REC Opinion
16 May 2019
REC opinion
Further Information Favourable Opinion