drugset

drugset / Trial / NCT00627523

Genotropin Treatment In Very Young Children Born Small For Gestational Age

NCT00627523 ↗

Phase 3 Completed 43 enrolled Pfizer

RandomizedParallel-groupOpen-labelTreatment

Summary

To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.

Timeline

Start: 2008-02
Primary completion: 2013-12
Completion: 2013-12

Publications

De Schepper J, Vanderfaeillie J, Mullis PE, Rooman R, Robertson A, Dilleen M, Gomez R, Wollmann HA. A 2-year multicentre, open-label, randomized, controlled study of growth hormone (Genotropin(R)) treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN) Study. Clin Endocrinol (Oxf). 2016 Mar;84(3):353-60. doi: 10.1111/cen.12968. Epub 2015 Nov 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Somatropin	Protein / enzyme biologic	0.035 mg/kg	Subcutaneous

Indications