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Practicability and Acceptability of Stylomax® in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00476385
First Posted: May 22, 2007
Last Update Posted: February 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose

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: None (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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476385


Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Marie SEBILLE, Dr Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00476385     History of Changes
Other Study ID Numbers: L_8912
First Submitted: May 21, 2007
First Posted: May 22, 2007
Last Update Posted: February 12, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases


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