NCT00476385

Brief Summary

Primary objective: to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for MAXOMAT®, in children, for 1 year.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 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

June 1, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

2.5 years

First QC Date

May 21, 2007

Last Update Submit

February 11, 2009

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

  • practicability/acceptability of the Stylomax pen

    at each visit

Secondary Outcomes (1)

  • tolerability : pain (evaluation on pain scale)

    at each visit

Study Arms (1)

somatropine

EXPERIMENTAL
Drug: somatropine

Interventions

somatropineDRUG

subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg

somatropine

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children over 3 years of age with growth hormone deficiency, requiring treatment with MAXOMAT® according to the criteria of the MA.

You may not qualify if:

  • 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

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Marie SEBILLE, Dr

    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

May 21, 2007

First Posted

May 22, 2007

Study Start

June 1, 2003

Primary Completion

December 1, 2005

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

FR(1)