Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency; Growth Retardation
Intervention: Somatropin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To assess the effect of long-term treatment by Genotonorm on linear growth
Clinical Details
Official title: Treatment With Recombinant Human Growth Hormone (Genotonorm) In Children With Short Stature Secondary To A Long Term Corticoid Therapy
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The main efficacy variable is the height SDS (SEMPE) before and after treatment.The standing height of the patients is measured during the inclusion visit and at each follow-up visit. The height measurements are always performed at the same time of the day by use of a wallmounted device (e.g. Harpenden Stadiometer). Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height. The body weight is measured by use of a balance scale. Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Pfizer Investigational Site, Paris, France
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting:
Starting date: February 1997
Ending date: October 2006
Last updated: June 3, 2008
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