IGF1 Generation Test

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00145457
• Date of registration: 01/09/2005
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: IGF1 Generation Test CAREL
• Scientific 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.
• Date of first enrolment: April 2001
• Target sample size: 82
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00145457
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 4 Years
Age maximum: 11 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Procedure: Radiography

Procedure: Blood sample

Primary Outcome(s)

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

Secondary ID(s)

307-MET-9002-040

A6281023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors