Effect of MAXOMAT ® on the Growth of Small Children to NO... | NCT00452725

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

NCT00452725

Sponsor

Sanofi

Status

Completed

Last Update Posted

Oct 5, 2010Estimated

Enrollment

36Actual

Phase

Phase 3

Conditions

Noonan Syndrome

Interventions

MAXOMAT ®, biosynthetic growth hormone

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1997

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Mar 23, 2007

First Submission Date that Met QC Criteria

Mar 26, 2007

First Posted Date

Mar 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2010

Last Update Posted Date

Oct 5, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MAXOMAT ®, biosynthetic growth hormone	Drug	2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Clinical and laboratory test safety		every 6 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Marie SEBILLE	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009634	Noonan Syndrome

Ancestor Terms

ID	Term
D019465	Craniofacial Abnormalities
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases
D006330	Heart Defects, Congenital

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019382	Human Growth Hormone

Ancestor Terms

ID	Term
D013006	Growth Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided