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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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16 December 2017 |
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Main ID: |
NCT00936403 |
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Date of registration:
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09/07/2009 |
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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 Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
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Scientific title:
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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 |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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31 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00936403 |
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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: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Czech Republic
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Denmark
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France
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Israel
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Macedonia, The Former Yugoslav Republic of
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Slovenia
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Spain
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Turkey
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United Kingdom
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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 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
- Growth hormone replacement treatment for at least three months
Exclusion Criteria:
- Evidence of tumour growth or malignant disease
- Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose
more than 126mg/dl)
Age minimum:
6 Years
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency in Children
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Growth Hormone Disorder
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Intervention(s)
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Drug: NNC126-0083
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Drug: somatropin
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Primary Outcome(s)
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Frequency of Adverse events (AEs)
[Time Frame: 0-10 days after dosing]
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Secondary Outcome(s)
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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]
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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]
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Secondary ID(s)
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NN8630-1824
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2008-008240-25
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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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