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

Sanofi306 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

306

Conditions

Fetal Growth Retardation

Interventions

somatropinDRUG

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

somatropinDRUG

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 11 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Paris, France

Outcomes

Primary Outcomes

Efficacy data : measurement of height

Time frame: at trimestrial visit

Secondary Outcomes

laboratory test assessment and evaluation of bone age

Time frame: at every other visit

measurement of anti-GH and anti-ECP antibodies

Time frame: one visit out of four

Tolerance data : undesirable events

Time frame: throughout the study

Data from ClinicalTrials.gov

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