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

NCT00452491 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2010-10-05

No results posted yet for this study

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

Conditions

  • Fetal Growth Retardation

Interventions

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

DRUG

somatropin

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

Sponsors & Collaborators

Principal Investigators

  • Marie SEBILLE, Dr · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-05-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00452491 on ClinicalTrials.gov