Status:

COMPLETED

Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age

Lead Sponsor:

Pfizer

Conditions:

Fetal Growth Retardation

Eligibility:

All Genders

4-9 years

Phase:

PHASE3

Brief Summary

To estimate the percentage of children with serum IGF-1 \> 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after...

Eligibility Criteria

Inclusion

  • Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.
  • Measured Height \< -2.5 Standard Deviation

Exclusion

  • Pubertal signs ie: testis volume \> or = 4 ml in boys and breast stage \> or = B2 (Tanner)
  • Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic insufficiency, neoplasia)

Key Trial Info

Start Date :

February 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2009

Estimated Enrollment :

57 Patients enrolled

Trial Details

Trial ID

NCT00174252

Start Date

February 1 2005

End Date

April 1 2009

Last Update

June 15 2010

Active Locations (22)

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Page 1 of 6 (22 locations)

1

Pfizer Investigational Site

Amiens, France, 80030

2

Pfizer Investigational Site

Angers, France, 49000

3

Pfizer Investigational Site

Besançon, France, 25030

4

Pfizer Investigational Site

Bordeaux, France, 33000

Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age | DecenTrialz