Genotropin Treatment In Very Young Children Born Small For Gestational Age
NCT ID: NCT00627523
Last Updated: 2014-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
43 participants
INTERVENTIONAL
2008-02-29
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active
The active treatment arm
Genotropin (PN-180,307) Somatropin
Injectable Genotropin
Control
Control
Control-no treatment
Control-no treatment
Interventions
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Genotropin (PN-180,307) Somatropin
Injectable Genotropin
Control-no treatment
Control-no treatment
Eligibility Criteria
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Inclusion Criteria
Born SGA (birth length and/or weight \<-2 SD for gestational age, using country-specific standards).
Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length between 12 and 18 months of age. Normal karyotype in girls to exclude Turners syndrome.
Exclusion Criteria
Severe prematurity (Gestational Age (GA) \<32 weeks of gestation). Ongoing catch-up growth (defined as growth velocity SDS at inclusion \>0) based on at least 4 months measurement interval).
Severe familial short stature defined as: Father's height below 155 cm or mother's height below 145 cm.
Defined neurological defects and/or severe neurodevelopmental delay.
19 Months
29 Months
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Universitair Ziekenhuis Brussel/Pediatrie
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen / Pediatrie
Edegem, , Belgium
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Ostrava, Detska klinika
Ostrava-Poruba, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
CHU Toulouse, Hôpital des Enfants, Service Endocrinologie
Toulouse, , France
Universitaetsklinikum Erlangen, Kinder- und Jugendklinik
Erlangen, , Germany
Centro di Endocrinologia Pediatrica, Dipartimento di Pediatria
Catania, , Italy
Policlinico Universitario, Istituto di Clinica Pediatrica
Messina, , Italy
Dipartimento Materno Infantile, UO di Pediatria e Neonatologia
Milan, , Italy
Dipartimento di Medicina Pediatrica, UO di Endocrinologia e Diabetologia
Roma, , Italy
Sophia Children's Hospital
Rotterdam, , Netherlands
Consorci Hospitalari Parc Tauli
Sabadell, Barcelona, Spain
Hospital Virgen Del Camino
Pamplona, Navarre, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain
Drottning Silvias Barn och Ungdomssjukhus
Gothenburg, , Sweden
Inselspital
Ch-3010 Bern, , Switzerland
Countries
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References
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De Schepper J, Vanderfaeillie J, Mullis PE, Rooman R, Robertson A, Dilleen M, Gomez R, Wollmann HA. A 2-year multicentre, open-label, randomized, controlled study of growth hormone (Genotropin(R)) treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN) Study. Clin Endocrinol (Oxf). 2016 Mar;84(3):353-60. doi: 10.1111/cen.12968. Epub 2015 Nov 25.
Related Links
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Other Identifiers
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2007-003949-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SGA
Identifier Type: OTHER
Identifier Source: secondary_id
A6281287
Identifier Type: -
Identifier Source: org_study_id
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