drugset / Trial / NCT00102817
Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.
Timeline
- Start
- 2003-05
- Primary completion
- 2006-12
- Completion
- 2006-12
Publications
- Results Cohen P, Rogol A, Kappelgaard A-M, Weng W, Germak J, Rosenfeld RG on behalf of the American Norditropin Study Group. Efficacy of IGF-I Based Growth Hormone (GH) Dose Titration in Non-GH Deficient (Non-GHD) Children with Short Stature Associated with IGF-I Deficiency (IGFD). Pediatric Academic Societies (PAS)/Lawson Wilkins Pediatric Endocrine Society (LWPES) 2007; Country: Canada City: Toronto
- Results Cohen P, Rosenfeld R, Rogol A, Kappelgaard A-M, Mak C, Germak J. Validation of the Efficacy and Safety of IGF-based Dose-titration in Children with Growth Failure Associated with Non-GH-deficient, IGF-I Deficiency: Results of Clinical Trial HGH 2147 on Behalf of the American Norditropin® Clinical Studies Group. 3rd International Congress of the Growth Hormone Research Society and the IGF Society 2006; Country: Japan City: Kobe
- Cohen P, Rogol AD, Weng W, Kappelgaard AM, Rosenfeld RG, Germak J; American Norditropin Study Group. Efficacy of IGF-based growth hormone (GH) dosing in nonGH-deficient (nonGHD) short stature children with low IGF-I is not related to basal IGF-I levels. Clin Endocrinol (Oxf). 2013 Mar;78(3):405-14. doi: 10.1111/cen.12014.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | 40 ug/kg | — |