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

Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00452725
Enrollment
36
Registered
2007-03-27
Start date
1997-10-31
Completion date
2010-07-31
Last updated
2010-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noonan Syndrome

Brief summary

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

Interventions

DRUGMAXOMAT ®, biosynthetic growth hormone

2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 15 Years
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.

Design outcomes

Primary

MeasureTime frame
Evaluation of height : gain in height and rate of growthat each visit (every 3 months) or every 6 months

Secondary

MeasureTime frame
Clinical and laboratory test safetyevery 6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026