Practicability and Acceptability of Stylomax® in Children

Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00476385

Enrollment

Registered

2007-05-22

Start date

2003-06-30

Completion date

Unknown

Last updated

2009-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

Brief summary

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

Interventions

DRUGsomatropine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

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.

Design outcomes

Primary

Measure	Time frame
practicability/acceptability of the Stylomax pen	at each visit

Secondary

Measure	Time frame
tolerability : pain (evaluation on pain scale)	at each visit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026