drugset / Trial / NCT00109733

Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency

NCT00109733

Phase 3 Completed 31 enrolled EMD Serono
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.

Timeline

Start
2005-01
Primary completion
2006-06
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatropin Protein / enzyme biologic 0.01 mg/kg Subcutaneous
Subject Somatropin Protein / enzyme biologic 0.03 mg/kg Subcutaneous