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

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.
ClinicalTrials.gov Identifier: NCT00452725
Recruitment Status : Completed
First Posted : March 27, 2007
Last Update Posted : October 5, 2010
Sponsor:
Information provided by:
Sanofi

Brief Summary:
  1. Clinical Objective : To improve the growth of these children
  2. Genetic objective : A study of the genetics of the syndrome

Condition or disease Intervention/treatment Phase
Noonan Syndrome Drug: MAXOMAT ®, biosynthetic growth hormone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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
Study Start Date : October 1997
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Somatropin
U.S. FDA Resources


Intervention Details:
    Drug: MAXOMAT ®, biosynthetic growth hormone
    2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration


Primary Outcome Measures :
  1. 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 :
  1. Clinical and laboratory test safety [ Time Frame: every 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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.


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): NCT00452725


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00452725     History of Changes
Other Study ID Numbers: MAX08
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: October 5, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Noonan Syndrome
Syndrome
Disease
Pathologic Processes
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