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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01973244
First Posted: October 31, 2013
Last Update Posted: March 26, 2015
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 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) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.

Condition Intervention Phase
Growth Hormone Disorder Growth Hormone Deficiency in Children Drug: NNC0195-0092 Drug: somatropin Phase 1

Study Type: Interventional
Study Design: 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) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

Resource links provided by NLM:


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

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

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

Enrollment: 32
Study Start Date: December 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC0195-0092 Drug: NNC0195-0092

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.

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.

  Eligibility

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)
  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): NCT01973244


Locations
Austria
Linz, Austria, A 4020
Belgium
Brussels, Belgium, 1090
France
Paris, France, 75015
Israel
Kfar Saba, Israel, 44281
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Slovenia
Ljubljana, Slovenia, 1525
Spain
Vitoria, Spain, 01009
Sweden
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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 Submitted: October 22, 2013
First Posted: October 31, 2013
Last Update Posted: March 26, 2015
Last Verified: March 2015

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