A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
NCT ID: NCT00936403
Last Updated: 2017-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2009-08-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NNC126-0083
NNC126-0083
One single dose administered in four dose levels in an escalating order
Norditropin NordiFlex®
somatropin
A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant
Interventions
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NNC126-0083
One single dose administered in four dose levels in an escalating order
somatropin
A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant
Eligibility Criteria
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Inclusion Criteria
* Pre-pubertal children
* Growth hormone replacement treatment for at least three months
Exclusion Criteria
* Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)
6 Years
12 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Brussels, , Belgium
Novo Nordisk Investigational Site
Ghent, , Belgium
Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Århus C, , Denmark
Novo Nordisk Investigational Site
Bron, , France
Novo Nordisk Investigational Site
Toulouse, , France
Novo Nordisk Investigational Site
Beersheba, , Israel
Novo Nordisk Investigational Site
Jerusalem, , Israel
Novo Nordisk Investigational Site
Kfar Saba, , Israel
Novo Nordisk Investigational Site
Petah Tikva, , Israel
Novo Nordisk Investigational Site
Skopje, , North Macedonia
Novo Nordisk Investigational Site
Ljubljana, , Slovenia
Novo Nordisk Investigational Site
Barcelona, , Spain
Novo Nordisk Investigational Site
Esplugues Llobregat, , Spain
Novo Nordisk Investigational Site
Santiago de Compostela, , Spain
Novo Nordisk Investigational Site
Vitoria-Gasteiz, , Spain
Novo Nordisk Investigational Site
Ankara, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Ankara, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Birmingham, , United Kingdom
Novo Nordisk Investigational Site
Cambridge, , United Kingdom
Countries
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References
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de Schepper J, Rasmussen MH, Gucev Z, Eliakim A, Battelino T. Long-acting pegylated human GH in children with GH deficiency: a single-dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics. Eur J Endocrinol. 2011 Sep;165(3):401-9. doi: 10.1530/EJE-11-0536. Epub 2011 Jul 1.
Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-008240-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN8630-1824
Identifier Type: -
Identifier Source: org_study_id
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