A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Фаза 2
Идёт, набор закрыт
NCT03878446
| Заболевание | Short Stature Children Born Small for Gestational Age |
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| Фаза | Фаза 2 |
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| Спонсор | Novo Nordisk A/S |
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| Статус | Идёт, набор закрыт |
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| Участники | 62 участн. |
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| Вмешательство | Somapacitan, Norditropin® |
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| Дата начала | 4.07.2019 |
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| Дата завершения | 5.05.2021 |
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| Публикация результатов | 20.06.2024 |
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Кратко
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.
Height Velocity
Baseline (week 0); week 26 · centimeter per year (cm/year)
| Norditropin 0.035 mg/kg/Day | 10.5 ± 2.0 centimeter per year (cm/year) |
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| Norditropin 0.067 mg/kg/Day | 11.9 ± 2.4 centimeter per year (cm/year) |
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| Somapacitan 0.16 mg/kg/Week | 8.9 ± 1.8 centimeter per year (cm/year) |
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| Somapacitan 0.20 mg/kg/Week | 11.1 ± 2.6 centimeter per year (cm/year) |
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| Somapacitan 0.24 mg/kg/Week | 11.2 ± 3.4 centimeter per year (cm/year) |
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| Treatment difference | -1.4 (95% CI -3.2–0.4) |
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