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

June 1, 2017 updated by: Ferring Pharmaceuticals

Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1034

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinics and private practices

Description

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

  • contraindications according to SPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Growth hormone
Children with growth hormone deficiency
Other: Growth hormone
Drug given by prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of ZOMACTON
Time Frame: Up to 5 years
measured by: body height, increase of body height per annum
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy measured by further parameters
Time Frame: 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
Up to 5 years
Safety of Zomacton and application device
Time Frame: Up to 5 years
measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Collaborators

Ferring Arzneimittel GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2007

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZOM/011207/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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