Status:
COMPLETED
A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml
- Pre-pubertal children
- Growth hormone replacement treatment for at least three months
Exclusion
- Evidence of tumour growth or malignant disease
- Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00936403
Start Date
August 1 2009
End Date
July 1 2010
Last Update
February 8 2017
Active Locations (21)
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1
Novo Nordisk Investigational Site
Brussels, Belgium, 1090
2
Novo Nordisk Investigational Site
Ghent, Belgium, 9000
3
Novo Nordisk Investigational Site
Prague, Czechia, 15018
4
Novo Nordisk Investigational Site
Århus C, Denmark, 8000