Practicability and Acceptability of Stylomax® in Children

Phase 3

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: somatropine

• Registration Number: NCT00476385
• Lead Sponsor: Sanofi

Brief Summary

Primary objective:

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2005-12
• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-11
• Last Update Posted: 2009-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
somatropine	somatropine	-

Primary Outcome Measures

Name	Time	Method
practicability/acceptability of the Stylomax pen	at each visit

Secondary Outcome Measures

Name	Time	Method
tolerability : pain (evaluation on pain scale)	at each visit

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Paris, France