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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Fetal Growth Retardation

Treatments: Drug: Genotonorm (Somatropin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00174252

A6281234

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Genotonorm (Somatropin)

Experimental group

Treatment:

Drug: Genotonorm (Somatropin)