Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

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Brief Title

Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

Official Title

Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.

Brief Summary

      To assess the effect of long-term treatment by Genotonorm on linear growth

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

The main efficacy variable is the height SDS (SEMPE) before and after treatment.

Condition

Growth Hormone Deficiency

Intervention

Somatropin

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

14

Start Date

February 1997

Completion Date

October 2006

Eligibility Criteria

        Inclusion Criteria:

          -  All the patients who have benefit during one year of a treatment by Genotonorm during
             the study 94-8123-014

          -  All patients who have stopped during one year will be included if a signed written
             informed consent

        Exclusion Criteria:

          -  Endocrine disease, except well substituted hypothyroidism

          -  Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)

Gender

All

Ages

6 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pfizer CT.gov Call Center, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT00174278

Organization ID

96-8123-018

Secondary IDs

A6281217

Study Sponsor

Pfizer

Study Sponsor

Pfizer CT.gov Call Center, Study Director, Pfizer

Verification Date

August 2008