Back to resultsIGF1 Generation Test (CAREL)
Primary Purpose
Growth Hormone Deficiency
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Blood sample
Radiography
Sponsored by
About this trial
This is an interventional treatment trial for Growth Hormone Deficiency
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00145457
Brief Title
IGF1 Generation Test
Acronym
CAREL
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 Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Type
Procedure
Intervention Name(s)
Radiography
Primary Outcome Measure Information:
Title
Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Pfizer Investigational Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Pfizer Investigational Site
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
Pfizer Investigational Site
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Pfizer Investigational Site
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 14
ZIP/Postal Code
75674
Country
France
Facility Name
Pfizer Investigational Site
City
Tarbes
ZIP/Postal Code
65013
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
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IGF1 Generation Test
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