English to Russian Medical Medical: Pharmaceuticals

Part Form for Children and Teenagers
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature.
The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®.
Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries.
You will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years.
You will have 17 clinic visits.
At 12 clinic visits blood samples will be collected.
Your parent(s) will fill in a diary after each injection you take.
1
Norditropin® given once a day – the medicine doctors can already prescribe.
Compare the change in height in children taking somapacitan and Norditropin®.
2
You are between 2.5 and 11 years old when you enter the study.
3
How will you take the study medicines?
You will get either somapacitan or Norditropin®.
You will be asked to inject the medicine with a pen with a thin and short needle.
The study doctor or nurse will show you how.
come to 17 visits at the clinic to see the study doctor.
at 7 of the clinic visits you cannot eat or drink, except water for 6 hours before the visit.
at 12 clinic visits you will have blood samples taken.
Numbing cream may be used to decrease discomfort.
A total of about XX mL (XX teaspoons) will be taken during the whole study
at 4 clinic visits the study doctor will measure your heartbeat (called electrocardiogram or ECG)
at 4 clinic visits an X-ray of your hand and wrist will be taken
as a boy, this means measuring the size of your testicles
Your parent(s) will be asked to record some information in a diary.
The following should be recorded:
what dose you inject
what part of your body you inject the medicine in (injection site).
Your parent(s) will be asked to complete short questionnaires e.g. about treatment burden at some visits to the clinic.
Study app
The diary and questionnaires are in a study app.
Your parent(s) can download the study app on a mobile phone.
This will also allow your parent(s) to receive reminders about the diary.
4
Norditropin®
During the first year in the study, you will get either somapacitan or Norditropin®.
Norditropin® is like the body’s own growth hormone.
Somapacitan is like Norditropin® but is only given once a week.
5
Side effects of somapacitan
These are the side effects we know about from other studies with somapacitan or similar products (Norditropin®).
These are the side effects we know about from use of Norditropin® (somatropin).
Norditropin® (somatropin) has no known effect on the ability to drive or use machines.
Pregnancy – information for girls and boys
Information about contraception included below should either be made **‘black mandatory’** or deleted before finalisation of local ‘agreement to take part form’.
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Do not take part in this study if you are pregnant, breastfeeding or planning to get pregnant.
We do not know how the study medicine may affect you or your baby.
If you take part in the study, and you are able to get pregnant, you and your male partner must use birth control.
Your study doctor will give you advice about this before the study starts.