NCT00452725

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 1997

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 5, 2010

Status Verified

October 1, 2010

Enrollment Period

12.8 years

First QC Date

March 23, 2007

Last Update Submit

October 4, 2010

Conditions

Noonan Syndrome

Outcome Measures

Primary Outcomes (1)

  • Evaluation of height : gain in height and rate of growth

    at each visit (every 3 months) or every 6 months

Secondary Outcomes (1)

  • Clinical and laboratory test safety

    every 6 months

Interventions

MAXOMAT ®, biosynthetic growth hormoneDRUG

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

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children and adolescents with Noonan's syndrome with a height \< -2 SD and no progressive cardiopathy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Noonan Syndrome

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Marie SEBILLE

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 27, 2007

Study Start

October 1, 1997

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 5, 2010

Record last verified: 2010-10

Locations

FR(1)