4467 REAL 8 Norditropin vs Somapacitan in children with short stature
Research type
Research Study
Full title
A study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design in children with short stature either born small for gestational age or with Turner syndrome ,Noonan syndrome, or idiopathic short stature.
IRAS ID
1005233
Contact name
Clinical Transparency Dept. (2834)
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2021-005607-13
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate the effect and safety of once-weekly subcutaneous (s.c.) treatment of somapacitan growth hormone (GH) compared to daily s.c. GH (Norditropin®) treatment in the following four indications of prepubertal children who need help to grow: Born small for gestational age (SGA) with no catch-up growth by 2 years of age or older, Turner syndrome (TS), Noonan syndrome (NS), or idiopathic short stature (ISS). The children will be randomised to receive either once weekly somapacitan or once daily Norditropin® for 52 weeks and then there will be a 104 week extension period when all children will receive somapacitan. Randomisation will be done 2:1 (somapacitan vs Norditropin®) for TS, NS and ISS, it will be 2:1:1 (somapacitan vs low dose Norditropin® vs higher dose Norditropin®) for SGA children. Children will need to attend the clinic 17 times during the entire course of the study where various assessments will be undertaken.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0115
Date of REC Opinion
12 Jul 2022
REC opinion
Further Information Favourable Opinion