CClinicalTrials.gg
CompletedNCT00145457CARELUpdated Jun 6, 2007

IGF1 Generation Test

A Phase 4 interventional study of Blood sample and Radiography in Growth Hormone Deficiency, sponsored by Pfizer. Completed at 8 sites in France. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2007-06-06.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
4 Years to 11 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Growth Hormone Deficiency

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03

In context

Dwarfism, Pituitary

164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.

This study's enrollment of 82 is above the median of 72 across 122 interventional studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Previous treatment with GH
  • Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants

Interventions

  • ProcedureBlood sample
  • ProcedureRadiography
06

What researchers measure

Primary outcomes

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

07

Study locations

8 sites
  • Pfizer Investigational Site
    Besançon, 25030, France
  • Pfizer Investigational Site
    Bordeaux, 33000, France
  • Pfizer Investigational Site
    Dunkerque, 59385, France
  • Pfizer Investigational Site
    Limoges Cedex, 87042, France
  • Pfizer Investigational Site
    Nice, 06202, France
  • Pfizer Investigational Site
    Paris Cedex 14, 75674, France
  • Pfizer Investigational Site
    Tarbes, 65013, France
  • Pfizer Investigational Site
    Toulouse Cedex 9, 31059, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00145457
Lead sponsor
Pfizer
First posted
Sep 5, 2005
Start date
Apr 2001
Completion
Jan 2005
Last update
Jun 6, 2007

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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