A Phase 4 interventional study of somatropin and somatropin in Foetal Growth Problem and Small for Gestational Age, sponsored by Novo Nordisk A/S. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment
This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
This study's enrollment of 57 is below the median of 101 across 117 interventional studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: somatropin
Drug: somatropin
Drug: somatropin
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion
Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray
Pubertal development, assessed according to Tanner method
Height velocity
Final height
Number of Adverse Events
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S