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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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 initiation of GH treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)