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A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: July 9, 2009
Last updated: October 16, 2016
Last verified: October 2016
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 blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.

Condition Intervention Phase
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Drug: NNC126-0083
Drug: somatropin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Frequency of Adverse events (AEs) [ Time Frame: 0-10 days after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administration [ Time Frame: Measured 10 days after dosing ] [ Designated as safety issue: No ]
  • IGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration [ Time Frame: Measured 10 days after dosing ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: August 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC126-0083 Drug: NNC126-0083
One single dose administered in four dose levels in an escalating order
Active Comparator: Norditropin NordiFlex® Drug: somatropin
A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • Evidence of tumour growth or malignant disease
  • Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00936403

Novo Nordisk Investigational Site
Brussels, Belgium, 1090
Novo Nordisk Investigational Site
Gent, Belgium, 9000
Czech Republic
Novo Nordisk Investigational Site
Prague 5, Czech Republic, 15018
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Novo Nordisk Investigational Site
BRON cedex, France, 69677
Novo Nordisk Investigational Site
Toulouse cedex 9, France, 31059
Novo Nordisk Investigational Site
Beer Sheva, Israel, 84101
Novo Nordisk Investigational Site
Jerusalem, Israel, 91240
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44281
Novo Nordisk Investigational Site
Petah Tikva, Israel, 49202
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1525
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
Novo Nordisk Investigational Site
Esplugues Llobregat, Spain, 08950
Novo Nordisk Investigational Site
Santiago de Compostela, Spain, 15706
Novo Nordisk Investigational Site
Vitoria, Spain, 01009
Novo Nordisk Investigational Site
Ankara, Turkey, 06100
Novo Nordisk Investigational Site
Ankara, Turkey
Novo Nordisk Investigational Site
Istanbul, Turkey, 34093
United Kingdom
Novo Nordisk Investigational Site
Cambridge, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S Identifier: NCT00936403     History of Changes
Other Study ID Numbers: NN8630-1824  2008-008240-25 
Study First Received: July 9, 2009
Last Updated: October 16, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Slovenia: Agency of Drugs and Medicinal Products of the Slovenian Republic
Spain: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicines and Healthcare Products
Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on October 25, 2016