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NCT00184756 Clinical Trial

Efficacy on Height in SGA Children Treated With Growth Hormone

Small for Gestational Age Clinical Trial

Official title:
Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00184756
Other study ID # GHLIQUID-1424
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated January 12, 2017
Start date November 2002
Est. completion date July 2006

Study information
Verified date January 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 and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.

Recruitment information / eligibility
Status Completed
Enrollment 151
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender All
Age group 3 Years to 7 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin

Locations
Country Name City State
Czech Republic Novo Nordisk Investigational Site Brno
Czech Republic Novo Nordisk Investigational Site Olomouc
Czech Republic Novo Nordisk Investigational Site Praha 1
Czech Republic Novo Nordisk Investigational Site Praha 10
Czech Republic Novo Nordisk Investigational Site Praha 5
Czech Republic Novo Nordisk Investigational Site Usti n. Labem
Finland Novo Nordisk Investigational Site Helsinki
Finland Novo Nordisk Investigational Site Kuopio
Finland Novo Nordisk Investigational Site Oulu
Germany Novo Nordisk Investigational Site Gotha
Germany Novo Nordisk Investigational Site Heidelberg
Germany Novo Nordisk Investigational Site Krefeld
Germany Novo Nordisk Investigational Site Leipzig
Germany Novo Nordisk Investigational Site Wuppertal
Israel Novo Nordisk Investigational Site Beer Sheva
Israel Novo Nordisk Investigational Site Haifa
Israel Novo Nordisk Investigational Site Petah Tikva
Israel Novo Nordisk Investigational Site Rehovot
Poland Novo Nordisk Investigational Site Cracow
Poland Novo Nordisk Investigational Site Gdansk
Poland Novo Nordisk Investigational Site Warszawa
Portugal Novo Nordisk Investigational Site Coimbra
Portugal Novo Nordisk Investigational Site Matosinhos
Portugal Novo Nordisk Investigational Site Porto
Portugal Novo Nordisk Investigational Site Vila Nova de Gaia
Spain Novo Nordisk Investigational Site Barcelona
Spain Novo Nordisk Investigational Site Esplugues Llobregat
Spain Novo Nordisk Investigational Site Granada
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 Santiago de Compostela
Spain Novo Nordisk Investigational Site Valencia
Sweden Novo Nordisk Investigational Site Helsingborg
Sweden Novo Nordisk Investigational Site Örebro
Sweden Novo Nordisk Investigational Site Stockholm

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

Countries where clinical trial is conducted

Czech Republic,  Finland,  Germany,  Israel,  Poland,  Portugal,  Spain,  Sweden, 

References & Publications (1)

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.

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate effect on Height in SGA Children Treated with Growth Hormone After 2 years of treatment
Secondary Appetite
Secondary Height SDS, yearly
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Completed NCT00557336 - Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age Phase 3
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Completed NCT00519844 - Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction Phase 4
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
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