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

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Other: Growth hormone

• Registration Number: NCT01365351
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-01
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-03
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1034

Inclusion Criteria

• therapeutic need according to SPC
• written informed consent

Exclusion Criteria

• contraindications according to SPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Growth hormone	Growth hormone	Children with growth hormone deficiency

Primary Outcome Measures

Name	Time	Method
Efficacy of ZOMACTON	Up to 5 years	measured by: body height, increase of body height per annum

Secondary Outcome Measures

Name	Time	Method
Efficacy measured by further parameters	Up to 5 years	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	Up to 5 years	measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory

Trial Locations

Locations (47)

Investigational Site, Dr.-Friedrich-Steiner-Straße 5; 🇩🇪 Datteln, Germany

Investigational Site, Alexandrinenstraße 5; 🇩🇪 Bochum, Germany

Investigational Site, Fetscherstraße 74; 🇩🇪 Dresden, Germany

Investigational Site, Geranienweg 7; 🇩🇪 Bad Langensalza, Germany

Investigational Site. Gotlindestraße 2 - 20; 🇩🇪 Berlin, Germany

Investigational Site, Kochstraße 2; 🇩🇪 Jena, Germany

Investigational Site, Koblenzer Str. 115-155; 🇩🇪 Koblenz, Germany

Investigational Site, Lyoner Straße 54; 🇩🇪 Frankfurt/Main, Germany

Investigational Site, Schwanenweg 20; 🇩🇪 Kiel, Germany

Investigational Site, Mathildenstraße 1; 🇩🇪 Freiburg, Germany

Investigational Site, Ettlinger Straße 27; 🇩🇪 Karlsruhe, Germany

Investigational Site, Albert-Schweitzer-Straße 33; 🇩🇪 Münster, Germany

Investigational Site; 🇩🇪 Marienstr. 6-8, Vechta, Germany

Investigational Site, Alter Markt 4; 🇩🇪 Bochum, Germany

Investigational Site, Hospitalstraße 44; 🇩🇪 Düren, Germany

Investigational Site, Brabeckstraße 153; 🇩🇪 Hannover, Germany

Investigational Site, Bleickenallee 38-40; 🇩🇪 Hamburg, Germany

Investigational Site, Werlerstraße 130; 🇩🇪 Hamm, Germany

Investigational Site, Seminarstraße 2; 🇩🇪 Heidelberg, Germany

Investigational Site, Kirrberger Straße; 🇩🇪 Homburg, Germany

Investigational Site, Im Neuenheimer Feld 430; 🇩🇪 Heidelberg, Germany

Investigational Site, Lindwurmstraße 4; 🇩🇪 München, Germany

Investigational Site, Johannisplatz 1; 🇩🇪 Leipzig, Germany

Investigational Site, Flemmingstraße 4; 🇩🇪 Chemnitz, Germany

Investigational Site, Düsseldorfer Straße 8; 🇩🇪 Düsseldorf, Germany

Investigational Site, Burgsteig 13; 🇩🇪 Bielefeld, Germany

Investigational Site, Hufelandstraße 55; 🇩🇪 Essen, Germany

Investigational Site, Ernst-Grube-Straße 40; 🇩🇪 Halle, Germany

Investigational Site, Pippinplatz 4; 🇩🇪 Gauting, Germany

Investigational Site, Kölner Platz 1; 🇩🇪 München, Germany

Investigational Site, Birkenallee 34; 🇩🇪 Magdeburg, Germany

Investigational Site, Leipziger Straße 44; 🇩🇪 Magdeburg, Germany

Investigational Site, Lutherplatz 40; 🇩🇪 Krefeld, Germany

Investigational Site, Kerpener Str. 62 (Haus 26); 🇩🇪 Köln, Germany

Investigational Site, Liebigstraße 20 a; 🇩🇪 Leipzig, Germany

Investigational Site, Promenadeplatz 12; 🇩🇪 München, Germany

Investigational Site, Helmut-Just-Straße 6; 🇩🇪 Neubrandenburg, Germany

Investigational Site, Dr.-Eden-Straße 10; 🇩🇪 Oldenburg, Germany

Investigational Site, St.-Johannis-Mühlgasse 19; 🇩🇪 Nürnberg, Germany

Investigational Site, Hauptkanal rechts 75; 🇩🇪 Papenburg, Germany

Investigational Site, Pettenkoferstraße 10; 🇩🇪 Rosenheim, Germany

Investigational Site, Eythstraße 24; 🇩🇪 Ulm, Germany

Investigational Site, Augustenburger Platz 1; 🇩🇪 Berlin, Germany

Investigational Site, Chausseestraße 119; 🇩🇪 Berlin, Germany

Investigational Site, Robert-Koch-Straße 40; 🇩🇪 Göttingen, Germany

Investigational Site, Lornsenstraße 4-6; 🇩🇪 Hamburg, Germany

Investigational Site, Am Markt 3; 🇩🇪 Gehrden, Germany