- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00476385
Practicability and Acceptability of Stylomax® in Children
February 11, 2009 updated by: Sanofi
Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.
Primary objective:
to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for MAXOMAT®, in children, for 1 year.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Paris, France
- Sanofi-Aventis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: somatropine
|
subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
practicability/acceptability of the Stylomax pen
Time Frame: at each visit
|
at each visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tolerability : pain (evaluation on pain scale)
Time Frame: at each visit
|
at each visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Marie SEBILLE, Dr, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
May 21, 2007
First Submitted That Met QC Criteria
May 21, 2007
First Posted (Estimate)
May 22, 2007
Study Record Updates
Last Update Posted (Estimate)
February 12, 2009
Last Update Submitted That Met QC Criteria
February 11, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- L_8912
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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