Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00476385 |
Date of registration:
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21/05/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Practicability and Acceptability of Stylomax® in Children
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Scientific title:
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Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children. |
Date of first enrolment:
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June 2003 |
Target sample size:
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12 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00476385 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Marie SEBILLE, Dr |
Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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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.
Age minimum:
3 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: somatropine
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Primary Outcome(s)
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practicability/acceptability of the Stylomax pen
[Time Frame: at each visit]
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Secondary Outcome(s)
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tolerability : pain (evaluation on pain scale)
[Time Frame: at each visit]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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