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

Fetal Growth Retardation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452491
• Other study ID #: FH5126A
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2007
• Last updated: October 4, 2010
• Start date: May 1993
• Est. completion date: April 2010

Study information

• Verified date: October 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

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
• somatropin
0.2 IU/kg/day 7 days per week given continuously for 3 years

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy data : measurement of height		at trimestrial visit	No
Secondary	laboratory test assessment and evaluation of bone age		at every other visit	No
Secondary	measurement of anti-GH and anti-ECP antibodies		one visit out of four	No
Secondary	Tolerance data : undesirable events		throughout the study	Yes