IGF1 Generation Test - Full Text View

Purpose

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.

Condition	Intervention	Phase
Growth Hormone Deficiency	Procedure: Blood sample Procedure: Radiography	Phase IV

Drug Information available for:

Insulin-like growth factor I Mecasermin rinfabate Somatotropin Somatropin X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.

Estimated Enrollment:	82
Study Start Date:	April 2001
Estimated Study Completion Date:	January 2005

Eligibility

Ages Eligible for Study:	4 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145457

Locations


France
	Pfizer Investigational Site
	Dunkerque, France, 59385
	Pfizer Investigational Site
	Limoges Cedex, France, 87042
	Pfizer Investigational Site
	Toulouse Cedex 9, France, 31059
	Pfizer Investigational Site
	Paris Cedex 14, France, 75674
	Pfizer Investigational Site
	Bordeaux, France, 33000
	Pfizer Investigational Site
	BesanÃ§on, France, 25030
	Pfizer Investigational Site
	Tarbes, France, 65013
	Pfizer Investigational Site
	Nice, France, 06202

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Links to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

Study ID Numbers:	307-MET-9002-040, A6281023
First Received:	September 1, 2005
Last Updated:	June 5, 2007
ClinicalTrials.gov Identifier:	NCT00145457
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Growth hormone deficiency

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00145457