Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00567385

Enrollment

176

Registered

2007-12-04

Start date

2003-03-10

Completion date

2004-03-22

Last updated

2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency in Children, Growth Hormone Disorder

Brief summary

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.

Interventions

DRUGsomatropin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

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)

Design outcomes

Primary

Measure	Time frame
Assessment of acceptance	after 12 weeks of treatment

Secondary

Measure	Time frame
Safety	—
Adverse Events (AE)	—
Compliance	—

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026