We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00452491
First Posted: March 27, 2007
Last Update Posted: October 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

  Contacts and Locations
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
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00452491     History of Changes
Other Study ID Numbers: FH5126A
First Submitted: March 23, 2007
First Posted: March 27, 2007
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