Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON

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

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site, Konrad-Adenauer-Allee 33, Augsburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

therapeutic need according to SPC
written informed consent

Exclusion criteria

contraindications according to SPC

Treatment and study plan

Growth hormone

Other

Drug given by prescription

Primary outcomes

Efficacy of ZOMACTON

Time frame: Up to 5 years

measured by: body height, increase of body height per annum

Secondary outcomes

Efficacy measured by further parameters

Time frame: Up to 5 years

measured by: weight, increase weight per annum sitting height, increase of sitting height per annum head circumference per annum bone age, increase of bone age per annum puberty development IGF-1, IGFBP-3 psychological cofactors
Safety of Zomacton and application device

Time frame: Up to 5 years

measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

Ferring Arzneimittel GmbH

Registry information

Official study title

Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency

Important dates

Study start: 2007
Primary completion: 2016
Study completion: 2016
First posted: Jun 3, 2011
Registry last updated: Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed