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IGF1 Generation Test (CAREL)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00145457
First received: September 1, 2005
Last updated: June 5, 2007
Last verified: May 2007

September 1, 2005
June 5, 2007
April 2001
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Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.
Same as current
Complete list of historical versions of study NCT00145457 on ClinicalTrials.gov Archive Site
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IGF1 Generation Test
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Growth Hormone Deficiency
  • Procedure: Blood sample
  • Procedure: Radiography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
January 2005
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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
Both
4 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00145457
307-MET-9002-040, A6281023
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Pfizer
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Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP