IGF1 Generation Test

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00145457

Acronym

CAREL

Enrollment

Registered

2005-09-05

Start date

2001-04-30

Completion date

2005-01-31

Last updated

2007-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

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.

Interventions

PROCEDUREBlood sample

PROCEDURERadiography

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 11 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026