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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00452491
First received: March 23, 2007
Last updated: October 4, 2010
Last verified: October 2010
History of Changes
  Purpose
  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

Condition Intervention Phase
Fetal Growth Retardation
 Drug: somatropin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Efficacy data : measurement of height [ Time Frame: at trimestrial visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • laboratory test assessment and evaluation of bone age [ Time Frame: at every other visit ] [ Designated as safety issue: No ]
  • measurement of anti-GH and anti-ECP antibodies [ Time Frame: one visit out of four ] [ Designated as safety issue: No ]
  • Tolerance data : undesirable events [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 306
Study Start Date: May 1993
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Active Comparator: 2 Drug: somatropin
0.2 IU/kg/day 7 days per week given continuously for 3 years

  Eligibility

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452491

Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Marie SEBILLE, Dr Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00452491     History of Changes
Other Study ID Numbers: FH5126A
Study First Received: March 23, 2007
Last Updated: October 4, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013