4245 Somapacitan vs Norditropin in children with short stature (REAL5)
Research type
Research Study
Full title
A dose-finding trial evaluating the effect and safety of once-weekly treatment of somapacitan compared to daily Norditropin® in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older
IRAS ID
261133
Contact name
Joanne Blair
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2018-000232-10
Duration of Study in the UK
1 years, 8 months, 9 days
Research summary
Most children that are small when they are born, compared to other babies born at the same stage of pregnancy, grow quickly and are a normal height by the time they are two years old. Children who are still short at the age of two years can be treated with growth hormone (GH) injections. At present, GH injections are given every day, but we think a new form of this medication could be given once a week. In this study we will see if children treated with GH injections given once a week grow as well as children treated with GH injections given daily.
Participants will be allocated treatment with the daily injection (Norditropin) at one of two doses (0.035mg/kg or 0.067mg/kg) or the new medication (somapacitan) at one of three doses (0.24mg/kg, 0.20mg/kg or 0.16mg/kg), randomly. This means that neither the participant, their parent or doctor can choose whether they are treated with Norditropin or somapacitan, or what dose they receive. The participants will be treated for one year.
During the first 13 weeks, participants will be seen every 4-5 weeks after the information, screening and randomisation visits are completed. Over the entire study there will be 10 visits. Participants will be weighed and measured at each visit except visit 4. The stage of puberty will be assessed 5 times during the study. Any change in health or new medications will be recorded. At the start and end of the study an ECG (heart tracing) will be performed, a blood sample will be collected at all visits. An x-ray of the hand and wrist will be obtained at the start of treatment) and end of treatment. At the end of the study we will compare how fast participants treated with Norditropin grow to those treated with somapacitan.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0834
Date of REC Opinion
10 Jul 2019
REC opinion
Further Information Favourable Opinion