Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 23, 2007
Last updated: October 4, 2010
Last verified: October 2010
  1. Clinical Objective : To improve the growth of these children
  2. Genetic objective : A study of the genetics of the syndrome

Condition Intervention Phase
Noonan Syndrome
Drug: MAXOMAT ®, biosynthetic growth hormone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Evaluation of height : gain in height and rate of growth [ Time Frame: at each visit (every 3 months) or every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical and laboratory test safety [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: October 1997
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MAXOMAT ®, biosynthetic growth hormone
    2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children and adolescents with Noonan's syndrome with a height < -2 SD and no progressive cardiopathy

Exclusion Criteria:

  • Age < 3 years
  • Height ≥ -2 SD

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00452725

Paris, France
Sponsors and Collaborators
Study Director: Marie SEBILLE Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00452725     History of Changes
Other Study ID Numbers: MAX08 
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:
Noonan Syndrome
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Connective Tissue Diseases
Craniofacial Abnormalities
Heart Defects, Congenital
Heart Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016