Practicability and Acceptability of Stylomax® in Children

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Growth hormone deficiency
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Brief Title

Practicability and Acceptability of Stylomax® in Children

Official Title

Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.

Brief Summary

      Primary objective:

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

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

practicability/acceptability of the Stylomax pen

Secondary Outcome

 tolerability : pain (evaluation on pain scale)

Condition

Growth Hormone Deficiency

Intervention

somatropine

Study Arms / Comparison Groups

 somatropine
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

12

Start Date

June 2003

Primary Completion Date

December 2005

Eligibility 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.

Gender

All

Ages

3 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Marie SEBILLE, Dr, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT00476385

Organization ID

L_8912

Study Sponsor

Sanofi

Study Sponsor

Marie SEBILLE, Dr, Study Director, Sanofi

Verification Date

February 2009