drugset / Trial / NCT00452491

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

NCT00452491

Phase 3 Completed 306 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
1993-05
Primary completion
2010-04
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Somatropin Protein / enzyme biologic 0.2 iu/kg