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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00452491
First received: March 23, 2007
Last updated: October 4, 2010
Last verified: October 2010

March 23, 2007
October 4, 2010
May 1993
April 2010   (final data collection date for primary outcome measure)
Efficacy data : measurement of height [ Time Frame: at trimestrial visit ] [ Designated as safety issue: No ]
measurement of height
Complete list of historical versions of study NCT00452491 on ClinicalTrials.gov Archive Site
  • laboratory test assessment and evaluation of bone age [ Time Frame: at every other visit ] [ Designated as safety issue: No ]
  • measurement of anti-GH and anti-ECP antibodies [ Time Frame: one visit out of four ] [ Designated as safety issue: No ]
  • Tolerance data : undesirable events [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • laboratory test assessment and evaluation of bone age
  • measurement of anti-GH and anti-ECP antibodies
Not Provided
Not Provided
 
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
  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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fetal Growth Retardation
  • 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
  • Experimental: 1
    Intervention: Drug: somatropin
  • Active Comparator: 2
    Intervention: Drug: somatropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
April 2010
April 2010   (final data collection date for primary outcome measure)

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.

Both
3 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00452491
FH5126A
No
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Marie SEBILLE, Dr Sanofi
Sanofi
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP