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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936403
First Posted: July 10, 2009
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]
  • 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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936403


Locations
Belgium
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
Denmark
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
France
Novo Nordisk Investigational Site
BRON cedex, France, 69677
Novo Nordisk Investigational Site
Toulouse cedex 9, France, 31059
Israel
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
Slovenia
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1525
Spain
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
Turkey
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
Birmingham, United Kingdom, B4 6NH
Novo Nordisk Investigational Site
Cambridge, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00936403     History of Changes
Other Study ID Numbers: NN8630-1824
2008-008240-25 ( EudraCT Number )
First Submitted: July 9, 2009
First Posted: July 10, 2009
Last Update Posted: February 8, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs