drugset / Trial / NCT00396097

Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

NCT00396097

Phase 3 Completed 316 enrolled Pfizer
RandomizedParallel-groupOpen-labelTreatment

Summary

To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

Timeline

Start
2006-12
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Somatropin Protein / enzyme biologic Other