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

Sponsor:	Novo Nordisk
Information provided by (Responsible Party):	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00936403

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 in growth hormone deficient children.

Condition	Intervention	Phase
Growth Hormone Deficiency (GHD)	Drug: NNC126-0083 Drug: somatropin	Phase II

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:

Genetics Home Reference related topics: combined pituitary hormone deficiency pseudoachondroplasia

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Frequency of Adverse events (AEs) [ Time Frame: 0-10 days after dosing ] [ Designated as safety issue: Yes ]

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: Yes ]
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: Yes ]

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: A	Drug: NNC126-0083 Each child in the cohort will receive either 1 dose of long-acting growth hormone or a daily dose of Norditropin NordiFlex for seven days.
Experimental: B	Drug: NNC126-0083 Each child in the cohort will receive either 1 dose of long-acting growth hormone or a daily dose of Norditropin NordiFlex for seven days.
Experimental: C	Drug: NNC126-0083 Each child in the cohort will receive either 1 dose of long-acting growth hormone or a daily dose of Norditropin NordiFlex for seven days.
Experimental: D	Drug: NNC126-0083 Each child in the cohort will receive either 1 dose of long-acting growth hormone or a daily dose of Norditropin NordiFlex for seven days.
Active Comparator: E	Drug: somatropin Each child in the cohort will receive either 1 dose of long-acting growth hormone or a daily dose of Norditropin NordiFlex for seven days.

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
GH replacement treatment for at least three months

Exclusion Criteria:

Evidence of tumour growth or malignant disease
GHD children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)

Contacts and Locations

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

Investigators

Study Director:

Lene Finnerup Nielsen, Msc

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Jul 1.

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00936403 History of Changes
Other Study ID Numbers:	NN8630-1824, 2008-008240-25
Study First Received:	July 9, 2009
Last Updated:	September 22, 2011
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 - French Health Products Safety Agency; 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 February 09, 2012