|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00174278 |
|
Date of registration:
|
09/09/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
|
|
Scientific 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. |
|
Date of first enrolment:
|
February 1997 |
|
Target sample size:
|
14 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00174278 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Pfizer CT.gov Call Center |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pfizer |
| | |
|
Key inclusion & exclusion 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)
Age minimum:
6 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Growth Hormone Deficiency
|
|
Growth Retardation
|
|
Intervention(s)
|
|
Drug: Somatropin
|
|
Primary Outcome(s)
|
|
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.
|
|
The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
|
|
Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.
|
|
The main efficacy variable is the height SDS (SEMPE) before and after treatment.
|
|
use of a wallmounted device (e.g. Harpenden Stadiometer).
|
|
The height measurements are always performed at the same time of the day by
|
|
Secondary ID(s)
|
|
A6281217
|
|
96-8123-018
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|