Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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2 August 2021 |
Main ID: |
EUCTR2013-000013-20-ES |
Date of registration:
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10/01/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A trial investigating the 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
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Scientific title:
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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 |
Date of first enrolment:
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02/01/2014 |
Target sample size:
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32 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000013-20 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Dose escalation If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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European Union
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France
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Israel
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Macedonia, the former Yugoslav Republic of
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Norway
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Slovenia
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Spain
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Sweden
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Switzerland
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Contacts
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Vandtaarnsvej 114, VTB
DK-2860
Soeborg
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Vandtaarnsvej 114, VTB
DK-2860
Soeborg
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Confirmed diagnosis of GHD as defined by two different GH stimulation tests, peak GH level ? 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 ? 7.0 ng/mL. - Pre-pubertal children at screening: - Boys: Tanner stage 1 and age ? 6 year and < 13 years - Girls: Tanner stage 1 and age ? 6 year and < 12 years - Body weight ?16.0 kg and ?50.0 kg - Stable GH replacement treatment ? 3 months Are the trial subjects under 18? yes Number of subjects for this age range: 32 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: - History or presence of malignancy - Overt diabetes mellitus (fasting blood glucose ? 7.0 mmol/L)
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Hormonal diseases [C19]
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Growth hormone deficiency in children MedDRA version: 16.1
Level: PT
Classification code 10056438
Term: Growth hormone deficiency
System Organ Class: 10014698 - Endocrine disorders
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Intervention(s)
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Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge Pharmaceutical Form: Solution for injection in cartridge INN or Proposed INN: n/a CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7-
Trade Name: Norditropin SimpleXx 10 mg Pharmaceutical Form: Solution for injection in cartridge INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Other descriptive name: SOMATROPIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7-
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Primary Outcome(s)
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Main Objective: To evaluate safety and tolerability of a single subcutaneous (s.c.) dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with growth hormone deficiency (GHD)
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Timepoint(s) of evaluation of this end point: From first administration of trial product and up until day 35 (final visit)
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Primary end point(s): Incidence of adverse events (AEs)
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Secondary Objective: - To evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of a single s.c. dose of NNC0195-0092 in children with GHD - To evaluate local tolerability (i.e. injection site reactions) of a single s.c. dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with GHD
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: From 0 to 168 hours after dosing
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Secondary end point(s): The area under the insulin-like growth factor I (IGF-I) concentration-time curve
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Secondary ID(s)
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NN8640-4042
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2013-000013-20-SI
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Source(s) of Monetary Support
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Novo Nordisk A/S
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Ethics review
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Status: Approved
Approval date: 15/11/2013
Contact:
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