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

This study has been completed.
Information provided by:
Sanofi 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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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   (Child)
Sexes Eligible for Study:   All
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00452725

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

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00452725     History of Changes
Other Study ID Numbers: MAX08
Study First Received: March 23, 2007
Last Updated: October 4, 2010

Additional relevant MeSH terms:
Noonan Syndrome
Pathologic Processes
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Connective Tissue Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 19, 2017