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Practicability and Acceptability of Stylomax® in Children

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: May 21, 2007
Last updated: February 11, 2009
Last verified: February 2009

Primary objective:

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

Condition Intervention Phase
Growth Hormone Deficiency Drug: somatropine Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • practicability/acceptability of the Stylomax pen [ Time Frame: at each visit ]

Secondary Outcome Measures:
  • tolerability : pain (evaluation on pain scale) [ Time Frame: at each visit ]

Enrollment: 12
Study Start Date: June 2003
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: somatropine Drug: somatropine
subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg


Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00476385

Paris, France
Sponsors and Collaborators
Study Director: Marie SEBILLE, Dr Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00476385     History of Changes
Other Study ID Numbers: L_8912
Study First Received: May 21, 2007
Last Updated: February 11, 2009

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases processed this record on July 21, 2017