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Growth Hormone DeficiencyNCT01365351

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

An observational study of Growth Hormone Deficiency, run by Ferring Pharmaceuticals at 59 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Growth Hormone Deficiency
What is being tested?
Growth hormone
How many people
1,034 participants
Where
59 sitesGermany
Study dates
1 Dec 2007to Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Clinics and private practices

Who may be able to join

  • therapeutic need according to SPC
  • written informed consent

Who cannot join

  • contraindications according to SPC

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

Germany59 sites

  • Investigational Site, Geranienweg 7

    Bad Langensalza

  • Investigational Site, Augustenburger Platz 1

    Berlin

  • Investigational Site, Chausseestraße 119

    Berlin

  • Investigational Site. Gotlindestraße 2 - 20

    Berlin

  • Investigational Site, Burgsteig 13

    Bielefeld

  • Investigational Site

    Blücherstr. 4, Erfurt

  • Investigational Site, Alexandrinenstraße 5

    Bochum

  • Investigational Site, Alter Markt 4

    Bochum

  • Investigational Site

    Chausseestr. 119, State of Berlin

  • Investigational Site, Flemmingstraße 4

    Chemnitz

  • Investigational Site, Kerpener Str. 62 (Haus 26)

    Cologne

  • Investigational Site, Dr.-Friedrich-Steiner-Straße 5

    Datteln

  • Investigational Site, Fetscherstraße 74

    Dresden

  • Investigational Site, Hospitalstraße 44

    Düren

  • Investigational Site, Düsseldorfer Straße 8

    Düsseldorf

  • Investigational Site

    Düsseldorfer Str. 1-7, Frankfurt (Main)

  • Investigational Site

    Elisabethenstr. 15, Ravensburg

  • Investigational Site

    Elisenstr. 12, Oldenburg

  • Investigational Site, Hufelandstraße 55

    Essen

  • Investigational Site, Lyoner Straße 54

    Frankfurt am Main

  • Investigational Site, Mathildenstraße 1

    Freiburg im Breisgau

  • Investigational Site

    Friedrichstr. 36-42, Dresden

  • Investigational Site, Pippinplatz 4

    Gauting

  • Investigational Site, Am Markt 3

    Gehrden

  • Investigational Site, Robert-Koch-Straße 40

    Göttingen

  • Investigational Site, Ernst-Grube-Straße 40

    Halle

  • Investigational Site, Bleickenallee 38-40

    Hamburg

  • Investigational Site, Lornsenstraße 4-6

    Hamburg

  • Investigational Site, Werlerstraße 130

    Hamm

  • Investigational Site, Brabeckstraße 153

    Hanover

  • Investigational Site, Im Neuenheimer Feld 430

    Heidelberg

  • Investigational Site, Seminarstraße 2

    Heidelberg

  • Investigational Site, Kirrberger Straße

    Homburg

  • Investigational Site, Kochstraße 2

    Jena

  • Investigational Site, Ettlinger Straße 27

    Karlsruhe

  • Investigational Site, Schwanenweg 20

    Kiel

  • Investigational Site, Koblenzer Str. 115-155

    Koblenz

  • Investigational Site

    Koblenzer Str. 115-155, Koblenz

  • Investigational Site

    Konrad-Adenauer-Allee 33, Augsburg

  • Investigational Site, Lutherplatz 40

    Krefeld

  • Investigational Site, Johannisplatz 1

    Leipzig

  • Investigational Site, Liebigstraße 20 a

    Leipzig

  • Investigational Site

    Loschgestr. 15, Erlangen

  • Investigational Site, Birkenallee 34

    Magdeburg

  • Investigational Site, Leipziger Straße 44

    Magdeburg

  • Investigational Site

    Marienstr. 6-8, Vechta

  • Investigational Site, Kölner Platz 1

    München

  • Investigational Site, Lindwurmstraße 4

    München

  • Investigational Site, Promenadeplatz 12

    München

  • Investigational Site, Albert-Schweitzer-Straße 33

    Münster

  • Investigational Site, Helmut-Just-Straße 6

    Neubrandenburg

  • Investigational Site, St.-Johannis-Mühlgasse 19

    Nuremberg

  • Investigational Site, Dr.-Eden-Straße 10

    Oldenburg

  • Investigational Site, Hauptkanal rechts 75

    Papenburg

  • Investigational Site, Pettenkoferstraße 10

    Rosenheim

  • Investigational Site

    Seminarstr. 2, Heidelberg

  • Investigational Site

    Stresemannallee 1-3, Frankfurt (Main)

  • Investigational Site, Eythstraße 24

    Ulm

  • Investigational Site

    Wilhelm-Breckow-Allee 20, Gummersbach

Other trials in Germany

About this study

Official title: 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.

Being tested
Growth hormone
Medical subject headings
Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Growth hormoneOther

    Drug given by prescription

Study groups in NCT01365351
Study groupRoleWhat they receive
Growth hormoneChildren with growth hormone deficiency
Receives: Other: Growth hormone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of ZOMACTON

    measured by: body height, increase of body height per annum

    Measured: Up to 5 years

Secondary outcomes (2)

  1. 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

    Measured: Up to 5 years

  2. Safety of Zomacton and application device

    measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2011 (estimated)
  2. Study start1 Dec 2007
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,034 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01365351
Sponsor's protocol ID
ZOM/011207/03
Status last verified
Jun 2017
First submitted
1 Jun 2011
Last updated
2 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Growth Hormone Deficiency, run by Ferring Pharmaceuticals at 59 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of ZOMACTON (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01365351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.

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