Practicability and Acceptability of Stylomax® in Children - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00476385

Purpose

Primary objective:

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

Condition	Intervention	Phase
Somatropin Deficiency	Drug: somatropine	Phase IV

Drug Information available for: Somatotropin Somatropin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Study of the Practicability and Acceptability of Stylomax® in Children With Somatotrope Deficiency

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

practicability/acceptability of the Stylomax pen [ Time Frame: at each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

tolerability : pain (evaluation on pain scale) [ Time Frame: at each visit ] [ Designated as safety issue: Yes ]

Study Start Date:	May 2003
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
somatropine: Experimental	Drug: somatropine subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476385

Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Marie SEBILLE, Dr

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	L8912
Study First Received:	May 21, 2007
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00476385
Health Authority:	France: Afssaps - French Health Products Safety Agency

ClinicalTrials.gov processed this record on January 16, 2009