Growth Hormone Deficiency Clinical Trial
— CARELOfficial 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.
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | January 2005 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
France,
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. |
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