CAREL: IGF1 Generation Test
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00145457
Collaborator
(none)
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Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Study Start Date
:
Apr 1, 2001
Study Completion Date
:
Jan 1, 2005
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
4 Years
to 11 Years
Sexes Eligible for Study:
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:
-
Previous treatment with GH
-
Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Besançon | France | 25030 | |
| 2 | Pfizer Investigational Site | Bordeaux | France | 33000 | |
| 3 | Pfizer Investigational Site | Dunkerque | France | 59385 | |
| 4 | Pfizer Investigational Site | Limoges Cedex | France | 87042 | |
| 5 | Pfizer Investigational Site | Nice | France | 06202 | |
| 6 | Pfizer Investigational Site | Paris Cedex 14 | France | 75674 | |
| 7 | Pfizer Investigational Site | Tarbes | France | 65013 | |
| 8 | Pfizer Investigational Site | Toulouse Cedex 9 | France | 31059 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00145457
Other Study ID Numbers:
- 307-MET-9002-040
- A6281023
First Posted:
Sep 5, 2005
Last Update Posted:
Jun 6, 2007
Last Verified:
May 1, 2007
Additional relevant MeSH terms: