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IGF1 Generation Test

NCT ID: NCT00145457

Last Updated: 2007-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Growth Hormone Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Blood sample

Intervention Type PROCEDURE

Radiography

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Besançon, , France

Site Status

Pfizer Investigational Site

Bordeaux, , France

Site Status

Pfizer Investigational Site

Dunkirk, , France

Site Status

Pfizer Investigational Site

Limoges, , France

Site Status

Pfizer Investigational Site

Nice, , France

Site Status

Pfizer Investigational Site

Paris, , France

Site Status

Pfizer Investigational Site

Tarbes, , France

Site Status

Pfizer Investigational Site

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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A6281023

Identifier Type: -

Identifier Source: secondary_id

307-MET-9002-040

Identifier Type: -

Identifier Source: org_study_id