Status:
COMPLETED
Efficacy on Height in SGA Children Treated With Growth Hormone
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Foetal Growth Problem
Small for Gestational Age
Eligibility:
All Genders
3-7 years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00184756
Start Date
November 1 2002
End Date
July 1 2006
Last Update
January 13 2017
Active Locations (37)
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1
Novo Nordisk Investigational Site
Brno, Czechia, 61300
2
Novo Nordisk Investigational Site
Olomouc, Czechia, 77520
3
Novo Nordisk Investigational Site
Prague, Czechia, 10081
4
Novo Nordisk Investigational Site
Prague, Czechia, 116 94