Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®

Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01731028

Enrollment

Registered

2012-11-21

Start date

2013-01-31

Completion date

2018-06-30

Last updated

2013-02-01

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

Conditions

Growth Hormone Deficiency

Brief summary

The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.

Interventions

DRUGSomatropin

Somatropin powder and solvent for solution for injection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Inclusion criteria

* therapeutic need according to the approved specific products characteristics (SPC)

Exclusion criteria

* contraindication according to the SPC

Design outcomes

Primary

Measure	Time frame
Efficacy of Zomacton® treatment measured by the increase in body height per annuum	5 years

Secondary

Measure	Time frame
Efficacy of Zomacton® treatment measured by the increase in body weight per annuum	5 years
Safety of Zomacton® and the application device measured by local adverse reactions to the application device	5 years

Outcome results

None listed

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