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

• Status: Completed
• Trial end date: 2002-10-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Hormones

Criteria

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