Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

Growth Hormone Deficiency Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174278
• Other study ID #: 96-8123-018
• Secondary ID: A6281217
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: August 4, 2008
• Start date: February 1997
• Est. completion date: October 2006

Study information

• Verified date: August 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

To assess the effect of long-term treatment by Genotonorm on linear growth

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism
• Dwarfism, Pituitary
• Growth Hormone Deficiency
• Growth Retardation

Intervention

Drug:
• Somatropin

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main efficacy variable is the height SDS (SEMPE) before and after treatment.
Primary	The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
Primary	The height measurements are always performed at the same time of the day by
Primary	use of a wallmounted device (e.g. Harpenden Stadiometer).
Primary	Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
Primary	The body weight is measured by use of a balance scale.
Primary	Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.

External Links

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