Genotropin Treatment In Very Young Children Born Small For Gestational Age (EGN)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Infant, Small for Gestational Age

Treatments: Drug: Genotropin (PN-180,307) Somatropin; Drug: Control-no treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00627523

A6281287

SGA (Other Identifier)

2007-003949-32 (EudraCT Number)

Details and patient eligibility

About

To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.

Enrollment: 43 patients

Sex: All

Ages: 19 to 29 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

Caucasian male or female subjects aged between 19-29 months at Screening Visit 1.

Born SGA (birth length and/or weight <-2 SD for gestational age, using country-specific standards).

Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length between 12 and 18 months of age. Normal karyotype in girls to exclude Turners syndrome.

Exclusion criteria

Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational age), if associated with dysmorphic features.

Severe prematurity (Gestational Age (GA) <32 weeks of gestation). Ongoing catch-up growth (defined as growth velocity SDS at inclusion >0) based on at least 4 months measurement interval).

Severe familial short stature defined as: Father's height below 155 cm or mother's height below 145 cm.

Defined neurological defects and/or severe neurodevelopmental delay.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Active

Experimental group

Description:

The active treatment arm

Treatment:

Drug: Genotropin (PN-180,307) Somatropin

Control

Experimental group

Description:

Control

Treatment:

Drug: Control-no treatment