Practicability and Acceptability of Stylomax® in Children

Sanofi

Status and phase: Completed; Phase 3

Conditions: Growth Hormone Deficiency

Treatments: Drug: somatropine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00476385

L_8912

Details and patient eligibility

About

Primary objective:

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

Enrollment: 12 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

somatropine

Experimental group

Treatment:

Drug: somatropine