Efficacy on Height in SGA Children Treated With Growth Hormone

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Small for Gestational Age; Foetal Growth Problem

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00184756

GHLIQUID-1424

Details and patient eligibility

About

This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.

Enrollment: 151 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
• Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion

Exclusion criteria

• Growth Hormone Deficiency (GHD)
• Treatment with any medical product which may interfere with GH effects
• Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind