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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01365351
Other study ID # ZOM/011207/03
Secondary ID
Status Completed
Phase N/A
First received June 1, 2011
Last updated June 1, 2017
Start date December 1, 2007
Est. completion date June 2016

Study information

Verified date June 2017
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1034
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- therapeutic need according to SPC

- written informed consent

Exclusion Criteria:

- contraindications according to SPC

Study Design


Intervention

Other:
Growth hormone
Drug given by prescription

Locations

Country Name City State
Germany Investigational Site, Geranienweg 7 Bad Langensalza
Germany Investigational Site, Augustenburger Platz 1 Berlin
Germany Investigational Site, Chausseestraße 119 Berlin
Germany Investigational Site. Gotlindestraße 2 - 20 Berlin
Germany Investigational Site, Burgsteig 13 Bielefeld
Germany Investigational Site Blücherstr. 4 Erfurt
Germany Investigational Site, Alexandrinenstraße 5 Bochum
Germany Investigational Site, Alter Markt 4 Bochum
Germany Investigational Site Chausseestr. 119 Berlin
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 Düsseldorfer Str. 1-7 Frankfurt (Main)
Germany Investigational Site Elisabethenstr. 15 Ravensburg
Germany Investigational Site Elisenstr. 12 Oldenburg
Germany Investigational Site, Hufelandstraße 55 Essen
Germany Investigational Site, Lyoner Straße 54 Frankfurt/Main
Germany Investigational Site, Mathildenstraße 1 Freiburg
Germany Investigational Site Friedrichstr. 36-42 Dresden
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, Bleickenallee 38-40 Hamburg
Germany Investigational Site, Lornsenstraße 4-6 Hamburg
Germany Investigational Site, Werlerstraße 130 Hamm
Germany Investigational Site, Brabeckstraße 153 Hannover
Germany Investigational Site, Im Neuenheimer Feld 430 Heidelberg
Germany Investigational Site, Seminarstraße 2 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 Koblenzer Str. 115-155 Koblenz
Germany Investigational Site, Kerpener Str. 62 (Haus 26) Köln
Germany Investigational Site Konrad-Adenauer-Allee 33 Augsburg
Germany Investigational Site, Lutherplatz 40 Krefeld
Germany Investigational Site, Johannisplatz 1 Leipzig
Germany Investigational Site, Liebigstraße 20 a Leipzig
Germany Investigational Site Loschgestr. 15 Erlangen
Germany Investigational Site, Birkenallee 34 Magdeburg
Germany Investigational Site, Leipziger Straße 44 Magdeburg
Germany Investigational Site Marienstr. 6-8 Vechta
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 Seminarstr. 2 Heidelberg
Germany Investigational Site Stresemannallee 1-3 Frankfurt (Main)
Germany Investigational Site, Eythstraße 24 Ulm
Germany Investigational Site Wilhelm-Breckow-Allee 20 Gummersbach

Sponsors (2)

Lead Sponsor Collaborator
Ferring Pharmaceuticals Ferring Arzneimittel GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of ZOMACTON measured by: body height, increase of body height per annum Up to 5 years
Secondary Efficacy measured by further parameters 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 Up to 5 years
Secondary Safety of Zomacton and application device measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory Up to 5 years
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