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

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ClinicalTrials.gov Identifier: NCT00452491
Recruitment Status : Completed
First Posted : March 27, 2007
Last Update Posted : October 5, 2010
Sponsor:
Information provided by:
Sanofi

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

Condition or disease Intervention/treatment Phase
Fetal Growth Retardation Drug: somatropin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 1993
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Efficacy data : measurement of height [ Time Frame: at trimestrial visit ]

Secondary Outcome Measures :
  1. laboratory test assessment and evaluation of bone age [ Time Frame: at every other visit ]
  2. measurement of anti-GH and anti-ECP antibodies [ Time Frame: one visit out of four ]
  3. Tolerance data : undesirable events [ Time Frame: throughout the study ]


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Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452491


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00452491     History of Changes
Other Study ID Numbers: FH5126A
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: October 5, 2010
Last Verified: October 2010

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