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

Phase 3

Completed

• Conditions: Fetal Growth Retardation
• Interventions: Drug: somatropin

• Registration Number: NCT00452491
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 1993-05
• Study First Submitted: 2007-03-23
• Study First Submitted QC: 2007-03-26
• Study First Posted: 2007-03-27
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-04
• Last Update Posted: 2010-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	somatropin	-
2	somatropin	-

Primary Outcome Measures

Name	Time	Method
Efficacy data : measurement of height	at trimestrial visit

Secondary Outcome Measures

Name	Time	Method
laboratory test assessment and evaluation of bone age	at every other visit
measurement of anti-GH and anti-ECP antibodies	one visit out of four
Tolerance data : undesirable events	throughout the study

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Paris, France