Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

Pfizer

Status and phase: Completed; Phase 3

Conditions: Growth Disorders; Intrauterine Growth Retardation

Treatments: Drug: Genotonorm

Study type: Interventional

Funder types: Industry

Identifiers

NCT01073605

A6281186, CTN 93-8122-001

93-8122-001

Details and patient eligibility

About

To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

Enrollment: 208 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronological age (CA) between 3 and 10 for girls
• Chronological age between 3 and 12 for boys
• Height for CA below - 2 SD
• Birth length for CA below -2SD

Exclusion criteria

• Endocrine disease except well-substituted hypothyroidism
• Sever chronic disease
• Skeletal dysplasia
• Known chromosomal aberration
• Ongoing treatment with steroids
• Known intrauterine infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 3 patient groups

Genotonorm A

Active Comparator group

Description:

Continuous 0.7 IU/kg/week or 0.03 mg/kg/day

Treatment:

Drug: Genotonorm

Drug: Genotonorm

Drug: Genotonorm

Genotonorm B

Active Comparator group

Description:

Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day

Treatment:

Drug: Genotonorm

Drug: Genotonorm

Drug: Genotonorm

Genotonorm C

Active Comparator group

Description:

Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day

Treatment:

Drug: Genotonorm

Drug: Genotonorm

Drug: Genotonorm