A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Phase 2
Active, not recruiting
NCT03878446
| Condition | Short Stature Children Born Small for Gestational Age |
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| Phase | Phase 2 |
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| Sponsor | Novo Nordisk A/S |
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| Status | Active, not recruiting |
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| Enrollment | 62 participants |
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| Interventions | Somapacitan, Norditropin® |
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| Start date | Jul 4, 2019 |
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| Completion date | May 5, 2021 |
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| Results posted | Jun 20, 2024 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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