Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Small for Gestational Age; Foetal Growth Problem

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519844

GHLIQUID-1670

2005-000318-11 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.

Enrollment: 5 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children treated for 3 years with Maxomat® because of small for gestational age
• Postnatal growth failure by the age of 3 years or more
• No associated growth hormone deficiency
• Height growth velocity greater than 2 cm/yr over the 12 month period preceding the inclusion
• Bone age no more than 13 years for girls and no more than 15 years for boys

Exclusion criteria

• Known, evolving tumour
• Hypertrophic cardiomyopathy
• Hypertension not controlled on maximum therapy
• Benign intracranial hypertension
• Known glucose intolerance or known diabetes mellitus
• Acute or active chronic hepatitis
• Chronic renal failure
• Chromosomal and/or genetic syndromes (other than Silver-Russell syndrome) or abnormality

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)