Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years

Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.

Timeline

Start

1999-04

Primary completion

2005-06

Completion

2005-06

Publications

• Results Argente J, Gracia R, Ibanez L, Oliver A, Borrajo E, Vela A, Lopez-Siguero JP, Moreno ML, Rodriguez-Hierro F; Spanish SGA Working Group. Improvement in growth after two years of growth hormone therapy in very young children born small for gestational age and without spontaneous catch-up growth: results of a multicenter, controlled, randomized, open clinical trial. J Clin Endocrinol Metab. 2007 Aug;92(8):3095-101. doi: 10.1210/jc.2007-0078. Epub 2007 May 29.

Drugs

Indications