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Clinical Trials/NCT00452491
NCT00452491
Completed
Phase 3

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

Sanofi1 site in 1 country306 target enrollmentMay 1993
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ConditionsFetal Growth Retardation
Interventionssomatropin
Drugssomatropin

Overview

Phase
Phase 3
Intervention
somatropin
Conditions
Fetal Growth Retardation
Sponsor
Sanofi
Enrollment
306
Locations
1
Primary Endpoint
Efficacy data : measurement of height
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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
Registry
clinicaltrials.gov
Start Date
May 1993
End Date
April 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sanofi

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: somatropin

2

Intervention: somatropin

Outcomes

Primary Outcomes

Efficacy data : measurement of height

Time Frame: at trimestrial visit

Secondary Outcomes

  • 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)

Study Sites (1)

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