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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00452725
First received: March 23, 2007
Last updated: October 4, 2010
Last verified: October 2010
History of Changes
  Purpose
  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:

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

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
  Eligibility

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

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

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

No publications provided

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
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
 Heart Diseases
Congenital Abnormalities
Connective Tissue Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013