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A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

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ClinicalTrials.gov Identifier: NCT01973244
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.

Condition or disease Intervention/treatment Phase
Growth Hormone Disorder Growth Hormone Deficiency in Children Drug: somapacitan Drug: somatropin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency
Actual Study Start Date : December 16, 2013
Actual Primary Completion Date : November 4, 2014
Actual Study Completion Date : November 4, 2014


Arm Intervention/treatment
Experimental: NNC0195-0092 (somapacitan) Drug: somapacitan

A single dose administered subcutaneously (s.c., under the skin) of 4 different doses of NNC0195-0092 in an escalating order.

Each subject will be allocated to one dose level only. After completion of each dose cohort, a safety evaluation will be conducted prior to dose escalation.

Other Name: NNC0195-0092

Active Comparator: Norditropin® Drug: somatropin
Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: From first administration of trial product and up until day 35 (final visit) ]

Secondary Outcome Measures :
  1. The area under the insulin-like growth factor I (IGF-I) concentration-time curve [ Time Frame: From 0 to 168 hours after dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of GHD (growth hormone deficiency) as defined by two different GH (growth hormone) stimulation tests, peak GH level below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test will be needed. If in accordance with country specific practice, growth hormone deficiency can be defined by only one GH stimulation test, peak GH level below or equal to 7.0 ng/ml.
  • Pre-pubertal children at screening. Boys: Tanner stage 1 and age above or equal to 6 years and below 13 years. Girls: Tanner stage 1 and age above or equal to 6 years and below 12 years
  • Body weight above or equal to 16.0 kg and below or equal to 50.0 kg
  • Stable GH replacement treatment for at least 3 months

Exclusion Criteria:

  • History or presence of malignancy
  • Overt diabetes mellitus (fasting blood glucose above or equal to 7.0 mmol/l)

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): NCT01973244


Locations
Austria
Novo Nordisk Investigational Site
Graz, Austria, 8036
Novo Nordisk Investigational Site
Linz, Austria, 4020
Novo Nordisk Investigational Site
Wien, Austria, A 1090
Belgium
Novo Nordisk Investigational Site
Brussels, Belgium, 1090
Novo Nordisk Investigational Site
Brussels, Belgium, 1200
France
Novo Nordisk Investigational Site
Paris, France, 75015
Novo Nordisk Investigational Site
Toulouse cedex 9, France, 31059
Israel
Novo Nordisk Investigational Site
Haifa, Israel, 31096
Novo Nordisk Investigational Site
Jerusalem, Israel, 91240
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44281
Novo Nordisk Investigational Site
Petah Tikva, Israel, 49202
Novo Nordisk Investigational Site
Tel Hashomer, Israel, 52621
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Norway
Novo Nordisk Investigational Site
Bergen, Norway, 5021
Slovenia
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1525
Spain
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
Novo Nordisk Investigational Site
Esplugues Llobregat(Barcelona), Spain, 08950
Novo Nordisk Investigational Site
Santiago de Compostela, Spain, 15706
Novo Nordisk Investigational Site
Vitoria, Spain, 01009
Sweden
Novo Nordisk Investigational Site
Stockholm, Sweden, 141 86
Switzerland
Novo Nordisk Investigational Site
Basel, Switzerland, 4031
Novo Nordisk Investigational Site
Genève, Switzerland, 1211
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01973244     History of Changes
Other Study ID Numbers: NN8640-4042
2013-000013-20 ( EudraCT Number )
U1111-1138-2206 ( Other Identifier: WHO )
REec-2014-0688 ( Registry Identifier: Spanish Register of Clinical Studies (REec) )
JapicCTI-142663 ( Registry Identifier: JAPIC )
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

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