Growth Hormone Deficiency Clinical Trial
Official title:
Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency
| Verified date | June 2017 |
| Source | Ferring Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals | Ferring Arzneimittel GmbH |
Germany,
| 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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