MedPath

IGF1 Generation Test

Phase 4
Completed
Conditions
Growth Hormone Deficiency
Registration Number
NCT00145457
Lead Sponsor
Pfizer
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
82
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Pfizer Investigational Site

🇫🇷

Toulouse Cedex 9, France

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