Idiopathic Short Stature Clinical Trial
— ISSOfficial 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
NCT number | NCT00488124 |
Other study ID # | NRA6280030 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 2005 |
Est. completion date | March 2011 |
Verified date | December 2020 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | March 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 10 Years |
Eligibility | Inclusion Criteria: - Severe growth retardation (< -2,5 height SDS and annual growth velocity (HV SDS) < 0 SD according to Reinken (1992) and parental adjusted target height < -1 SD according to Tanner (1986) - Chronological age > 4 and < 10 years, prepubertal children; for girls: Tanner breast stage B = 1, for boys: testis volume = 3 ml - Any disease which is NOT part of the registered indications for GH treatment in Germany - Written informed consent from both parents and from the patients if she/he is able to receive and understand the information - GH treatment requested by an expert in pediatric endocrinology Exclusion Criteria: - Participation in any other clinical study - Unable to follow the and/or comprehend the protocol ( e.g. severe mental retardation) - Previous history of intolerance or hypersensitivity to the study drug - History of malignancy - Chromosomal anomalies with increased risk for malignancy |
Country | Name | City | State |
---|---|---|---|
Germany | Kinderklinik, Universitätsklinikum der RWTH Aachen, Pauwelsstraße 30 | Aachen | |
Germany | Klinik und Poliklinik für Kinder und Jugendliche der Technischen Universität Dresden, Fetscherstr. 74 | Dresden | |
Germany | Klinik für Kinder und Jugendliche, Schwerpunkt Kinder-Endokrinologie und - Diabetologie, Loschgestr. 15 | Erlangen | |
Germany | Klinik für Päd. Hämatologie, Onkologie und Endokrinologie, Zentrum für Kinderheilkunde, der Universität Duisburg-Essen, Hufelandstrasse 55 | Essen | |
Germany | Kinder- und Jugendärztin, Pippinplatz 4 | Gauting | |
Germany | Endokrinologikum Hamburg, Lornsenstrasse 4 - 6 | Hamburg | |
Germany | Kinderarztpraxis, Brabeckstrasse 153 | Hannover | |
Germany | Universitätsklinik für Kinder- und Jugendliche, Abt. Kinderheilkunde, Im Neuenheimer Feld 430 | Heidelberg | |
Germany | Universitätsklinik für Kinder- und Jugendmedizin, Kirrberger Strasse | Homburg/Saar | |
Germany | Klinik u. Poliklinik für Kinder und Jugendliche, Med. Einrichtungen der Universität Köln, Joseph-Stelzmann-Strasse 9 | Köln | |
Germany | Zentrum für Frauen und Kindermedizin, Liebigstrasse 20 a | Leipzig | |
Germany | Klinik für Allgemeine Pädiatrie und Neonatologie, Otto-von-Guericke-Universität Magdeburg, Leipziger Straße 44 | Magdeburg | |
Germany | Klinik für Kinderheilkunde und Jugendmedizin, Sektion Pädiatrische Endokrinologie, Hoppe-Seyler-Straße 1 | Tübingen |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To show an improvement of height, change in height (SDS) under GH treatment one year after visit 2 (start of GH therapy). | one and two years of observation | ||
Secondary | To show an increase in height velocity >1 SD compared to pretreatment height velocity, to confirm good clinical and biological safety of GH treatment in these patients (e.g. adverse events, serum IGF-I, fasting blood glucose and insulin) | one and two years of observation period |
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