IGF1 Generation Test (CAREL)

June 5, 2007 updated by: Pfizer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion

January 1, 2005

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

June 6, 2007

Last Update Submitted That Met QC Criteria

June 5, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-MET-9002-040
  • A6281023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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