Practicability and Acceptability of Stylomax® in Children

Growth Hormone Deficiency Clinical Trial

Official title:

Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476385
• Other study ID #: L_8912
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2007
• Last updated: February 11, 2009
• Start date: June 2003

Study information

• Verified date: February 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Primary objective:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

Drug:
• somatropine
subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	practicability/acceptability of the Stylomax pen		at each visit	No
Secondary	tolerability : pain (evaluation on pain scale)		at each visit	Yes