Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
This study has been completed.
Information provided by:
First received: September 9, 2005
Last updated: August 4, 2008
Last verified: August 2008
To assess the effect of long-term treatment by Genotonorm on linear growth
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency metatropic dysplasia pseudoachondroplasiaU.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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.
|Study Start Date:||February 1997|
|Study Completion Date:||October 2006|
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