Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00174278|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 5, 2008
|Condition or disease||Intervention/treatment||Phase|
|Growth Hormone Deficiency Growth Retardation||Drug: Somatropin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||February 1997|
|Actual Study Completion Date :||October 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174278
|Pfizer Investigational Site|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|