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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01365351
First received: June 1, 2011
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Growth Hormone Deficiency
Other: Growth hormone

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Efficacy of ZOMACTON [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    measured by: body height, increase of body height per annum


Secondary Outcome Measures:
  • Efficacy measured by further parameters [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory


Estimated Enrollment: 400
Study Start Date: November 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Growth hormone
Children with growth hormone deficiency
Other: Growth hormone
Drug given by prescription

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinics and private practices

Criteria

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

  • contraindications according to SPC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365351

  Hide Study Locations
Locations
Germany
Investigational Site
Konrad-Adenauer-Allee 33, Augsburg, Germany
Investigational Site
Chausseestr. 119, Berlin, Germany
Investigational Site
Friedrichstr. 36-42, Dresden, Germany
Investigational Site
Blücherstr. 4, Erfurt, Germany
Investigational Site
Loschgestr. 15, Erlangen, Germany
Investigational Site
Düsseldorfer Str. 1-7, Frankfurt (Main), Germany
Investigational Site
Stresemannallee 1-3, Frankfurt (Main), Germany
Investigational Site
Wilhelm-Breckow-Allee 20, Gummersbach, Germany
Investigational Site
Seminarstr. 2, Heidelberg, Germany
Investigational Site
Koblenzer Str. 115-155, Koblenz, Germany
Investigational Site
Elisenstr. 12, Oldenburg, Germany
Investigational Site
Elisabethenstr. 15, Ravensburg, Germany
Investigational Site
Marienstr. 6-8, Vechta, Germany
Investigational Site, Geranienweg 7
Bad Langensalza, Germany
Investigational Site. Gotlindestraße 2 - 20
Berlin, Germany
Investigational Site, Augustenburger Platz 1
Berlin, Germany
Investigational Site, Chausseestraße 119
Berlin, Germany
Investigational Site, Burgsteig 13
Bielefeld, Germany
Investigational Site, Alexandrinenstraße 5
Bochum, Germany
Investigational Site, Alter Markt 4
Bochum, Germany
Investigational Site, Flemmingstraße 4
Chemnitz, Germany
Investigational Site, Dr.-Friedrich-Steiner-Straße 5
Datteln, Germany
Investigational Site, Fetscherstraße 74
Dresden, Germany
Investigational Site, Hospitalstraße 44
Düren, Germany
Investigational Site, Düsseldorfer Straße 8
Düsseldorf, Germany
Investigational Site, Hufelandstraße 55
Essen, Germany
Investigational Site, Lyoner Straße 54
Frankfurt/Main, Germany
Investigational Site, Mathildenstraße 1
Freiburg, Germany
Investigational Site, Pippinplatz 4
Gauting, Germany
Investigational Site, Am Markt 3
Gehrden, Germany
Investigational Site, Robert-Koch-Straße 40
Göttingen, Germany
Investigational Site, Ernst-Grube-Straße 40
Halle, Germany
Investigational Site, Lornsenstraße 4-6
Hamburg, Germany
Investigational Site, Bleickenallee 38-40
Hamburg, Germany
Investigational Site, Werlerstraße 130
Hamm, Germany
Investigational Site, Brabeckstraße 153
Hannover, Germany
Investigational Site, Seminarstraße 2
Heidelberg, Germany
Investigational Site, Im Neuenheimer Feld 430
Heidelberg, Germany
Investigational Site, Kirrberger Straße
Homburg, Germany
Investigational Site, Kochstraße 2
Jena, Germany
Investigational Site, Ettlinger Straße 27
Karlsruhe, Germany
Investigational Site, Schwanenweg 20
Kiel, Germany
Investigational Site, Koblenzer Str. 115-155
Koblenz, Germany
Investigational Site, Lutherplatz 40
Krefeld, Germany
Investigational Site, Kerpener Str. 62 (Haus 26)
Köln, Germany
Investigational Site, Johannisplatz 1
Leipzig, Germany
Investigational Site, Liebigstraße 20 a
Leipzig, Germany
Investigational Site, Birkenallee 34
Magdeburg, Germany
Investigational Site, Leipziger Straße 44
Magdeburg, Germany
Investigational Site, Kölner Platz 1
München, Germany
Investigational Site, Lindwurmstraße 4
München, Germany
Investigational Site, Promenadeplatz 12
München, Germany
Investigational Site, Albert-Schweitzer-Straße 33
Münster, Germany
Investigational Site, Helmut-Just-Straße 6
Neubrandenburg, Germany
Investigational Site, St.-Johannis-Mühlgasse 19
Nürnberg, Germany
Investigational Site, Dr.-Eden-Straße 10
Oldenburg, Germany
Investigational Site, Hauptkanal rechts 75
Papenburg, Germany
Investigational Site, Pettenkoferstraße 10
Rosenheim, Germany
Investigational Site, Eythstraße 24
Ulm, Germany
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01365351     History of Changes
Other Study ID Numbers: ZOM/011207/03
Study First Received: June 1, 2011
Last Updated: April 23, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014