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CompletedNCT00476385Updated Feb 12, 2009

Practicability and Acceptability of Stylomax® in Children

A Phase 3 interventional study of somatropine in Growth Hormone Deficiency, sponsored by Sanofi. Completed at 1 site in France. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2009-02-12.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
3 Years to 18 Years
Sex
All
01

Study summary

Primary objective:

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

02

Conditions studied

  • Growth Hormone Deficiency

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03

In context

Dwarfism, Pituitary

171 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.

This study's enrollment of 12 is below the median of 69 across 127 interventional studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

Sanofi is the lead sponsor of 1,548 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    somatropine

    Drug: somatropine

Interventions

  • Drugsomatropine

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

06

What researchers measure

Primary outcomes

  1. practicability/acceptability of the Stylomax pen

    Time frame: at each visit

Secondary outcomes

  1. tolerability : pain (evaluation on pain scale)

    Time frame: at each visit

07

Study locations

1 site
  • Sanofi-Aventis
    Paris, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00476385
Lead sponsor
Sanofi
First posted
May 22, 2007
Start date
Jun 2003
Primary completion
Dec 2005
Last update
Feb 12, 2009

Study contacts

Marie SEBILLE, Dr
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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