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| Name | Class |
|---|---|
| Ferring Arzneimittel GmbH | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growth hormone | Children with growth hormone deficiency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth hormone | Other | Drug given by prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ZOMACTON | measured by: body height, increase of body height per annum | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Safety of Zomacton and application device |
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Inclusion Criteria:
Exclusion Criteria:
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Clinics and private practices
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Konrad-Adenauer-Allee 33 | Augsburg | Germany | |||
| Investigational Site |
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measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory |
| Up to 5 years |
| 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 | Chausseestr. 119 | State of Berlin | Germany |
| Investigational Site | Marienstr. 6-8 | Vechta | 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, Alexandrinenstraße 5 | Bochum | Germany |
| Investigational Site, Alter Markt 4 | Bochum | Germany |
| Investigational Site, Flemmingstraße 4 | Chemnitz | Germany |
| Investigational Site, Kerpener Str. 62 (Haus 26) | Cologne | 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 am Main | Germany |
| Investigational Site, Mathildenstraße 1 | Freiburg im Breisgau | 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 | Hanover | 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, Lutherplatz 40 | Krefeld | 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 | Nuremberg | 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 |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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