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Somatropin in SGA Children Due to IUGR
NCT00557336Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2003
- Primary completion
- Jun 2005
- Countries
- 1
- Sponsor
- Novo Nordisk
- Modality
- Hormone, rProtein (Recombinant Protein), Biologic
- Drugs
- somatropin
- Conditions
- Small for gestational age (SGA)
01
Overview
Phase 3 trial of somatropin in Small for gestational age (SGA), sponsored by Novo Nordisk. Primary endpoint: Height gain according to birth group, age of onset, the treatment and Tanner stage at 12 months. Started Jul 2003; status: completed.
02
Design
1 armSomatropin
Somatropin treatment
03
Who it enrols
Children born small for gestational age (SGA) due to IUGR, aged 4 to 12/13.5 years, with insufficient catch-up growth (height <= -2.5 SDS) and normal GH response.
04
Endpoints
Primary
Height gain according to birth group, age of onset, the treatment and Tanner stage
Secondary
Height SDS for bone age
Height velocity SDS for bone age
Height velocity for chronological age
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