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:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00936403
First received: July 9, 2009
Last updated: August 2, 2012
Last verified: August 2012
  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
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

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936403

Locations
Belgium
Brussels, Belgium, 1090
Denmark
Århus C, Denmark, 8000
France
Toulouse cedex 9, France, 31059
Israel
Jerusalem, Israel, 91240
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Slovenia
Ljubljana, Slovenia, 1525
Spain
Vitoria, Spain, 01009
United Kingdom
Cambridge, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lene Finnerup Nielsen, Msc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00936403     History of Changes
Other Study ID Numbers: NN8630-1824, 2008-008240-25
Study First Received: July 9, 2009
Last Updated: August 2, 2012
Health Authority: Slovenia: Agency of Drugs and Medicinal Products of the Slovenian Republic
Belgium: Federal Agency for Medicines and Healthcare Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Israel: Ministry of Health

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014