Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Novo Nordisk A/S176 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

176

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children

Interventions

somatropinDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Novo Nordisk Investigational Site

Altunizade-Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Assessment of acceptance

Time frame: after 12 weeks of treatment

Secondary Outcomes

Safety

Adverse Events (AE)

Compliance

Data from ClinicalTrials.gov

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