NCT00452491

MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Fetal Growth Retardation

Interventions

Type	Name	Description
DRUG	somatropin	0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years
DRUG	somatropin	0.2 IU/kg/day 7 days per week given continuously for 3 years

Timeline

• Start date: 1993-05-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-03-27
• Last updated: 2010-10-05

Locations

1 site across 1 country: France