Growth Hormone Deficiency Clinical Trial
Official title:
Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.
NCT number | NCT00476385 |
Other study ID # | L_8912 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | May 21, 2007 |
Last updated | February 11, 2009 |
Start date | June 2003 |
Primary objective:
to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for
MAXOMAT®, in children, for 1 year.
Status | Completed |
Enrollment | 12 |
Est. completion date | |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 18 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Sanofi-Aventis | Paris |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | practicability/acceptability of the Stylomax pen | at each visit | No | |
Secondary | tolerability : pain (evaluation on pain scale) | at each visit | Yes |
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