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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00476385
Other study ID # L_8912
Secondary ID
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. completion date
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


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
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