IGF1 Generation Test (CAREL)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00145457 |
Recruitment Status :
Completed
First Posted : September 5, 2005
Last Update Posted : June 6, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Growth Hormone Deficiency | Procedure: Blood sample Procedure: Radiography | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 82 participants |
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 : | April 2001 |
Study Completion Date : | January 2005 |

- 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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Ages Eligible for Study: | 4 Years to 11 Years (Child) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145457
France | |
Pfizer Investigational Site | |
Besançon, France, 25030 | |
Pfizer Investigational Site | |
Bordeaux, France, 33000 | |
Pfizer Investigational Site | |
Dunkerque, France, 59385 | |
Pfizer Investigational Site | |
Limoges Cedex, France, 87042 | |
Pfizer Investigational Site | |
Nice, France, 06202 | |
Pfizer Investigational Site | |
Paris Cedex 14, France, 75674 | |
Pfizer Investigational Site | |
Tarbes, France, 65013 | |
Pfizer Investigational Site | |
Toulouse Cedex 9, France, 31059 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
ClinicalTrials.gov Identifier: | NCT00145457 |
Other Study ID Numbers: |
307-MET-9002-040 A6281023 |
First Posted: | September 5, 2005 Key Record Dates |
Last Update Posted: | June 6, 2007 |
Last Verified: | May 2007 |
Dwarfism, Pituitary Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine |
Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |