Clinical Trials Logo
  1. Home
  2. Growth Hormone Deficiency
  3. NCT00145457
  4. Details
NCT00145457 Clinical Trial

IGF1 Generation Test

Growth Hormone Deficiency Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00145457
Other study ID # 307-MET-9002-040
Secondary ID A6281023
Status Completed
Phase Phase 4
First received September 1, 2005
Last updated June 5, 2007
Start date April 2001
Est. completion date January 2005

Study information
Verified date May 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 11 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sample

• Radiography

Locations
Country Name City State
France Pfizer Investigational Site Besançon
France Pfizer Investigational Site Bordeaux
France Pfizer Investigational Site Dunkerque
France Pfizer Investigational Site Limoges Cedex
France Pfizer Investigational Site Nice
France Pfizer Investigational Site Paris Cedex 14
France Pfizer Investigational Site Tarbes
France Pfizer Investigational Site Toulouse Cedex 9

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.
See also
  Status Clinical Trial Phase
Recruiting NCT02243852 - Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) N/A
Completed NCT01440686 - Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers Phase 1
Completed NCT00990340 - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method Phase 4
Completed NCT00235599 - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children. N/A
Completed NCT00149708 - Consequence of Lifetime Isolated Growth Hormone Deficiency N/A
Completed NCT00459940 - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients N/A
Completed NCT01157793 - A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood Phase 4
Completed NCT00004365 - Study of Pituitary Size and Function in Familial Dwarfism of Sindh N/A
Recruiting NCT00227253 - Chromosome 18 Clinical Research Center
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Completed NCT01090778 - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I) Phase 2
Completed NCT00965484 - Genotropin Study Assessing Use of Injection Pen Phase 3
Completed NCT01062529 - Peripheral Metabolic Effects of Somatostatin N/A
Completed NCT00616278 - National Cooperative Growth Study in CKD N/A
Completed NCT02693522 - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency Phase 3
Recruiting NCT02908958 - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency Phase 4
Terminated NCT01243892 - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device N/A
Withdrawn NCT00638287 - Inter-Assay Growth Hormone and IGF-I Variability N/A
Completed NCT00957671 - Anterior Pituitary Hormone Replacement in Traumatic Brain Injury Phase 4