Practicability and Acceptability of Stylomax® in Children

Sanofi12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Growth Hormone Deficiency

Interventions

somatropineDRUG

subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Paris, France

Outcomes

Primary Outcomes

practicability/acceptability of the Stylomax pen

Time frame: at each visit

Secondary Outcomes

tolerability : pain (evaluation on pain scale)

Time frame: at each visit

Data from ClinicalTrials.gov

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