Clinical trial NCT00557336: Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age
Official title: Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR
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: 2007-11-14
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.


Eligibility criteria: Inclusion Criteria:

* Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
* Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
* Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
* Normal response to GH stimulation test (greater than 10 ng/mL)

Exclusion Criteria:

* Diabetes
* Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
* Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
* History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
* Previous or ongoing growth hormone therapy

Primary outcomes:
measure: Height gain according to birth group, age of onset, the treatment and Tanner stage
timeFrame: during 12 months of treatment
Secondary outcomes:
measure: Height SDS for bone age
timeFrame: during 12 months of treatment
measure: Height velocity SDS for bone age
timeFrame: during 12 months of treatment
measure: Height velocity for chronological age
timeFrame: during 12 months of treatment
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Novo Nordisk Investigational Site
city: Alicante
country: Spain
facility: Novo Nordisk Investigational Site
city: Almería
country: Spain
facility: Novo Nordisk Investigational Site
city: Badajoz
country: Spain
facility: Novo Nordisk Investigational Site
city: Badalona
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Calella de la Costa
country: Spain
facility: Novo Nordisk Investigational Site
city: Cáceres
country: Spain
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Spain
facility: Novo Nordisk Investigational Site
city: El Palmar
country: Spain
facility: Novo Nordisk Investigational Site
city: Elche
country: Spain
facility: Novo Nordisk Investigational Site
city: Esplugues Llobregat
country: Spain
facility: Novo Nordisk Investigational Site
city: Getafe
country: Spain
facility: Novo Nordisk Investigational Site
city: Granada
country: Spain
facility: Novo Nordisk Investigational Site
city: Granollers
country: Spain
facility: Novo Nordisk Investigational Site
city: Huelva
country: Spain
facility: Novo Nordisk Investigational Site
city: Jaén
country: Spain
facility: Novo Nordisk Investigational Site
city: Las Palmas
country: Spain
facility: Novo Nordisk Investigational Site
city: Leganés
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: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Martorell
country: Spain
facility: Novo Nordisk Investigational Site
city: Mataró
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Palma de Mallorca
country: Spain
facility: Novo Nordisk Investigational Site
city: Pamplona
country: Spain
facility: Novo Nordisk Investigational Site
city: Sabadell
country: Spain
facility: Novo Nordisk Investigational Site
city: Salamanca
country: Spain
facility: Novo Nordisk Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novo Nordisk Investigational Site
city: Santander
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Tarrasa
country: Spain
facility: Novo Nordisk Investigational Site
city: Vitoria
country: Spain
facility: Novo Nordisk Investigational Site
city: Zaragoza
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: