Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Condition(s) targeted: Growth Hormone Deficiency (GHD)

Intervention: somatropin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Asude Ademogullari, BSc, Study Director, Affiliation: Novo Nordisk Saglik Urunleri Tic. Ltd. St.

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 dificiency.

Official title: Evaluating Acceptance of the New Liquid Growth Hormone Formulation, Norditropin® SimpleXx®, in Children With Growth Hormone Deficiency

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: Assessment of acceptance

Secondary outcome:

Safety

Adverse Events (AE)

Compliance

Minimum age: 3 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Growth failure due to growth hormone insufficiency (GHD)

- Turner syndrome: established diagnosis according to sex chromosome analysis, or

- Growth retadation 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)

Altunizade-Istanbul, Turkey

Clinical Trials at Novo Nordisk

Starting date: March 2003
Last updated: December 3, 2007