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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00452725
• Date of registration: 23/03/2007
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome
• Scientific title: Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome
• Date of first enrolment: October 1997
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00452725
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Marie SEBILLE
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 3 Years
Age maximum: 15 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Noonan Syndrome

Intervention(s)

Drug: MAXOMAT ®, biosynthetic growth hormone

Primary Outcome(s)

Evaluation of height : gain in height and rate of growth [Time Frame: at each visit (every 3 months) or every 6 months]

Secondary Outcome(s)

Clinical and laboratory test safety [Time Frame: every 6 months]

Secondary ID(s)

MAX08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors