A Cohort of Pre-pubertal Children for the Study of Optimization of Methods of Administration of the Biosynthetic Growth Hormone MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation

NCT00452491 Phase 3 COMPLETED

1. To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens 2. To specify the best period of treatment 3. To assess the efficacy of treatment based on final adult height of these children

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	306
Start date	1993-05
Completion	2010-04

Conditions

• Fetal Growth Retardation

Interventions

• somatropin
• somatropin

Primary outcomes

• Efficacy data : measurement of height — at trimestrial visit

Countries

France