Back to resultsEffect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome
Primary Purpose
Noonan Syndrome
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
MAXOMAT ®, biosynthetic growth hormone
Sponsored by
About this trial
This is an interventional treatment trial for Noonan Syndrome
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
Evaluation of height : gain in height and rate of growth
Secondary Outcome Measures
Clinical and laboratory test safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00452725
Brief Title
Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome
Official Title
Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical Objective : To improve the growth of these children
Genetic objective : A study of the genetics of the syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noonan Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MAXOMAT ®, biosynthetic growth hormone
Intervention Description
2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration
Primary Outcome Measure Information:
Title
Evaluation of height : gain in height and rate of growth
Time Frame
at each visit (every 3 months) or every 6 months
Secondary Outcome Measure Information:
Title
Clinical and laboratory test safety
Time Frame
every 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie SEBILLE
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome
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