MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-Pubertal Children - Full Text View

Purpose

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

Condition	Intervention	Phase
Fetal Growth Retardation	Drug: somatropin	Phase III

ChemIDplus related topics:

Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Efficacy data : measurement of height [ Time Frame: at trimestrial visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	300
Study Start Date:	May 1993
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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
2: Active Comparator	Drug: somatropin 0.2 IU/kg/day 7 days per week given continuously for 3 years

Eligibility

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:

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452491

Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	Marie SEBILLE, Dr	Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	FH 5126 A
First Received:	March 23, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00452491
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Fetal Diseases

Pregnancy Complications

Growth Disorders

Fetal Growth Retardation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00452491