Trial | NCT00452491  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    somatropin ...

  • Study Participants

    306
To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens
To specify the best period of treatment
To assess the efficacy of treatment based on final adult height of these children
Study Started
May 31
1993
Primary Completion
Apr 30
2010
Study Completion
Apr 30
2010
Last Update
Oct 05
2010
Estimate

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

1 Experimental

2 Active Comparator

Criteria 

Inclusion Criteria:

Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.)
Height Less Than or Equal to -3 SD

Exclusion Criteria:

Age less than 3 years

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
No Results Posted