Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Growth Hormone Deficiency in Children; Growth Hormone Disorder

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567385

GHLIQUID-1515

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.

Enrollment: 176 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Growth failure due to growth hormone insufficiency (GHD)
• Turner syndrome: established diagnosis according to sex chromosome analysis, or
• Growth retardation in children with chronic renal disorders

Exclusion criteria

• Pregnancy
• Breast feeding women
• Suspected or know allergy to trial product
• Participating in any other trial involving other investigational products within the last 3 months
• Previous participation in the trial
• Other daily injection therapy (non-growth hormone, e.g insulin-therapy)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)