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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01973244 |
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Date of registration:
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22/10/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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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, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency |
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Date of first enrolment:
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December 16, 2013 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01973244 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Austria
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Belgium
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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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Telephone:
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Email:
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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 (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)
Age minimum:
6 Years
Age maximum:
13 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Disorder
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Growth Hormone Deficiency in Children
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Intervention(s)
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Drug: somapacitan
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Drug: somatropin
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Primary Outcome(s)
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Incidence of adverse events (AEs)
[Time Frame: From first administration of trial product and up until day 35 (final visit)]
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Secondary Outcome(s)
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The area under the insulin-like growth factor I (IGF-I) concentration-time curve
[Time Frame: From 0 to 168 hours after dosing]
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Secondary ID(s)
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REec-2014-0688
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NN8640-4042
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2013-000013-20
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U1111-1138-2206
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JapicCTI-142663
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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