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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00452491

Enrollment

306

Registered

2007-03-27

Start date

1993-05-31

Completion date

2010-04-30

Last updated

2010-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Growth Retardation

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

Interventions

DRUGsomatropin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 11 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Efficacy data : measurement of height	at trimestrial visit

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026