Growth Hormone Deficiency, Growth Retardation
Conditions
Brief summary
To assess the effect of long-term treatment by Genotonorm on linear growth
Interventions
DRUGSomatropin
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France
Outcome results
None listed