Clinical trial NCT00184756: Efficacy on Height in SGA Children Treated With Growth Hormone
Official title: Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Foetal Growth Problem
Small for Gestational Age
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 151
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.


Eligibility criteria: Inclusion Criteria:

* Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
* Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion

Exclusion Criteria:

* Growth Hormone Deficiency (GHD)
* Treatment with any medical product which may interfere with GH effects
* Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders

Primary outcomes:
measure: Evaluate effect on Height in SGA Children Treated with Growth Hormone
timeFrame: After 2 years of treatment
Secondary outcomes:
measure: Appetite
measure: Height SDS, yearly
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Olomouc
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Praha 10
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Praha 1
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Praha 5
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Usti n. Labem
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Kuopio
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Gotha
country: Germany
facility: Novo Nordisk Investigational Site
city: Heidelberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Krefeld
country: Germany
facility: Novo Nordisk Investigational Site
city: Leipzig
country: Germany
facility: Novo Nordisk Investigational Site
city: Wuppertal
country: Germany
facility: Novo Nordisk Investigational Site
city: Beer Sheva
country: Israel
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Rehovot
country: Israel
facility: Novo Nordisk Investigational Site
city: Cracow
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Coimbra
country: Portugal
facility: Novo Nordisk Investigational Site
city: Matosinhos
country: Portugal
facility: Novo Nordisk Investigational Site
city: Porto
country: Portugal
facility: Novo Nordisk Investigational Site
city: Vila Nova de Gaia
country: Portugal
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Esplugues Llobregat
country: Spain
facility: Novo Nordisk Investigational Site
city: Granada
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Santiago de Compostela
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Helsingborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Örebro
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Phillip M, Lebl J, Zuckerman-Levin N, Korpal-Szczyrska M, Sales Marques J, Ibáñez L on behalf of the European Norditropin SGA study group. Multinational study in short SGA children: evaluation of the effect of three different growth hormone dose regimens. European Society for Paediatric Endocrinology (ESPE) 2007; Country: Finland City: Helsinki