Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age

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

NCT00557336

GHLIQUID-1523

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.

Enrollment: 160 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
• Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
• Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
• Normal response to GH stimulation test (greater than 10 ng/mL)

Exclusion criteria

• Diabetes
• Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
• Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
• History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
• Previous or ongoing growth hormone therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)