IGF1 Generation Test

Growth Hormone Deficiency Clinical Trial

— CAREL  

Official title:

A Multicentre Study on the Capacity of the IGF-1 Stimulation Test to Predict the Growth Promoting Effect of Standard and High Doses of Genotonorm® in Prepubertal Children With Growth Hormone Deficiency.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145457
• Other study ID #: 307-MET-9002-040
• Secondary ID: A6281023
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2005
• Last updated: June 5, 2007
• Start date: April 2001
• Est. completion date: January 2005

Study information

• Verified date: May 2007
• 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 predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

Inclusion Criteria:

• Male or female aged of more than 4 years.

• GHD defined as a peak GH level < 20 mUI/ml at two different pharmacological GH provocative tests including one done with two pharmacological agents and both performed within the year before the inclusion, according to the current recommendations of the French Health Authorities

Exclusion Criteria:

• Previous treatment with GH

• Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

Procedure:
• Blood sample

• Radiography

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Besançon
France	Pfizer Investigational Site	Bordeaux
France	Pfizer Investigational Site	Dunkerque
France	Pfizer Investigational Site	Limoges Cedex
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Paris Cedex 14
France	Pfizer Investigational Site	Tarbes
France	Pfizer Investigational Site	Toulouse Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.