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A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

Locations

Not recruiting

Start date

10/08/2022

Identifiers

Trial ID NN8640-4467,
NCT number NCT05330325,
Eudract number 2021-005607-13

Summary

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. The study will last for about 3 years. The participants 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. Which treatment the participants get is decided by chance.

Trial Overview:

Condition

SGA, Turner Syndrome, Noonan Syndrome, ISS

Treatment

DRUG: Somapacitan

DRUG: Norditropin®

Study type

INTERVENTIONAL

Trial duration

Aug 10 2022 - Oct 29 2027

Participants

399

Phase

III

Are you eligible?

Gender

Male and female

Age

2 to 10 years old

Questions or concerns

Do you have any question about what it’s like being a clinical volunteer? Have a look at our answers to frequently asked questions.

This site contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of a healthcare professional and should not be construed as providing advice or making a recommendation. The information on this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific product is correct for a particular patient. If you have questions regarding any information contained on this site you should consult a physician.