Clinical trial NCT01365351: Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON
Official title: Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring Arzneimittel GmbH
First posted: 2011-06-03
Enrollment: 1034
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinics and private practices

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* therapeutic need according to SPC
* written informed consent

Exclusion Criteria:

* contraindications according to SPC

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