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NCT00557336 Clinical Trial

Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age

Small for Gestational Age Clinical Trial

Official title:
Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00557336
Other study ID # GHLIQUID-1523
Secondary ID
Status Completed
Phase Phase 3
First received November 12, 2007
Last updated February 27, 2017
Start date July 28, 2003
Est. completion date June 29, 2005

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date June 29, 2005
Est. primary completion date June 29, 2005
Accepts healthy volunteers No
Gender All
Age group 2 Years to 14 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin

Locations
Country Name City State
Spain Novo Nordisk Investigational Site Albacete
Spain Novo Nordisk Investigational Site Alicante
Spain Novo Nordisk Investigational Site Almería
Spain Novo Nordisk Investigational Site Badajoz
Spain Novo Nordisk Investigational Site Badalona
Spain Novo Nordisk Investigational Site Barcelona
Spain Novo Nordisk Investigational Site Barcelona
Spain Novo Nordisk Investigational Site Cáceres
Spain Novo Nordisk Investigational Site Calella de la Costa
Spain Novo Nordisk Investigational Site Córdoba
Spain Novo Nordisk Investigational Site El Palmar
Spain Novo Nordisk Investigational Site Elche
Spain Novo Nordisk Investigational Site Esplugues Llobregat
Spain Novo Nordisk Investigational Site Getafe
Spain Novo Nordisk Investigational Site Granada
Spain Novo Nordisk Investigational Site Granollers
Spain Novo Nordisk Investigational Site Huelva
Spain Novo Nordisk Investigational Site Jaén
Spain Novo Nordisk Investigational Site Las Palmas
Spain Novo Nordisk Investigational Site Leganés
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Málaga
Spain Novo Nordisk Investigational Site Martorell
Spain Novo Nordisk Investigational Site Mataró
Spain Novo Nordisk Investigational Site Palma de Mallorca
Spain Novo Nordisk Investigational Site Pamplona
Spain Novo Nordisk Investigational Site Sabadell
Spain Novo Nordisk Investigational Site Salamanca
Spain Novo Nordisk Investigational Site Santa Cruz de Tenerife
Spain Novo Nordisk Investigational Site Santander
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Tarrasa
Spain Novo Nordisk Investigational Site Vitoria
Spain Novo Nordisk Investigational Site Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Height gain according to birth group, age of onset, the treatment and Tanner stage during 12 months of treatment
Secondary Height SDS for bone age during 12 months of treatment
Secondary Height velocity SDS for bone age during 12 months of treatment
Secondary Height velocity for chronological age during 12 months of treatment
See also
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Completed NCT01245374 - Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents Phase 4
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Completed NCT00184717 - Growth Hormone Treatment in Children Born Small for Gestational Age (SGA) Phase 3
Recruiting NCT01604395 - Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children
Terminated NCT00597480 - Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH) Phase 4
Completed NCT01543867 - Safety and Efficacy of Long-term Somatropin Treatment in Children N/A
Recruiting NCT02964793 - Effects of Serial Plotting on Fundal Height Charts on Identification and Outcomes of Small for Gestational Age Infants N/A
Recruiting NCT04798690 - Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

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