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Sponsored by: |
University of Erlangen-Nürnberg |
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Information provided by: | University of Erlangen-Nürnberg |
ClinicalTrials.gov Identifier: | NCT00488124 |
Growth hormone therapy will improve the height of short statured children with pathological conditions that lead to growth retardation. Growth hormone therapy will show an increase in height velocity >1 SD compared to pretreatment height velocity. and the therapy will be safe.
Condition | Intervention | Phase |
---|---|---|
Short Stature |
Drug: somatropin (Genotropin® treatment) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin: A Prospective, Longitudinal Non-Randomised, Open, Phase II Study |
Estimated Enrollment: | 120 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Growth hormone (GH, Somatropin, e.g. Genotropin®) is approved in the treatment of children in specific indications. However, besides the benefit in approved indications, a benefit can also be achieved in other pathological conditions that lead to growth retardation. However, because of their relative low frequency and the long duration of GH studies in children, few data or only case reports on GH treatment are available in these conditions. Nevertheless, published data have suggested a benefit of GH treatment in children suffering from some of those diseases and pediatric endocrinologists sometimes request GH treatment for those children to improve growth rate. This protocol is designed to allow such children with severe growth retardation to be treated with GH and will allow those children to be carefully followed-up and finally evaluated at the end of the GH treatment period.
Ages Eligible for Study: | 4 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Klinik für Kinder und Jugendliche, Schwerpunkt Kinder-Endokrinologie und - Diabetologie, Loschgestr. 15 | |
Erlangen, Germany, 91054 | |
Universitätsklinik für Kinder- und Jugendliche, Abt. Kinderheilkunde, Im Neuenheimer Feld 430 | |
Heidelberg, Germany, 69120 | |
Klinik für Päd. Hämatologie, Onkologie und Endokrinologie, Zentrum für Kinderheilkunde, der Universität Duisburg-Essen, Hufelandstrasse 55 | |
Essen, Germany, 45122 | |
Klinik und Poliklinik für Kinder und Jugendliche der Technischen Universität Dresden, Fetscherstr. 74 | |
Dresden, Germany, 01307 | |
Zentrum für Frauen und Kindermedizin, Liebigstrasse 20 a | |
Leipzig, Germany, 04103 | |
Kinder- und Jugendärztin, Pippinplatz 4 | |
Gauting, Germany, 82131 | |
Endokrinologikum Hamburg, Lornsenstrasse 4 - 6 | |
Hamburg, Germany, 22767 | |
Kinderarztpraxis, Brabeckstrasse 153 | |
Hannover, Germany, 30539 | |
Klinik für Allgemeine Pädiatrie und Neonatologie, Otto-von-Guericke-Universität Magdeburg, Leipziger Straße 44 | |
Magdeburg, Germany, 39112 | |
Klinik für Kinderheilkunde und Jugendmedizin, Sektion Pädiatrische Endokrinologie, Hoppe-Seyler-Straße 1 | |
Tübingen, Germany, 72076 | |
Universitätsklinik für Kinder- und Jugendmedizin, Kirrberger Strasse | |
Homburg/Saar, Germany, 66421 | |
Klinik u. Poliklinik für Kinder und Jugendliche, Med. Einrichtungen der Universität Köln, Joseph-Stelzmann-Strasse 9 | |
Köln, Germany, 50931 | |
Kinderklinik, Universitätsklinikum der RWTH Aachen, Pauwelsstraße 30 | |
Aachen, Germany, 52074 |
Study Chair: | Helmuth-Günther Doerr, Prof. Dr. | Friedrich-Alexander-Universität Erlangen-Nürnberg |
Responsible Party: | Childrens´ hospital ( Professor Dr. med. Doerr ) |
Study ID Numbers: | NRA6280030 |
Study First Received: | June 18, 2007 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00488124 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
short stature |