Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Growth Hormone Deficiency in Children; Genetic Disorder; Turner Syndrome; Growth Hormone Disorder

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563926

GHLIQUID-1315

Details and patient eligibility

About

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

Enrollment: 168 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written Informed Consent by patient and/or guardian/parents
• Patients with one of the following diagnosis: Growth failure due to growth hormone deficiency (GHD), Turner syndrome, or growth retardation in children with chronic renal disorders
• Patients who are willing to inject themselves and answer questionnaires or young patients whose parents/guardian are willing to inject their child and answer questionnaires
• Patients on growth hormone therapy for at least 6 weeks before entering the trial

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

Somatropin

Experimental group

Treatment:

Drug: somatropin