A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Disorder; Growth Hormone Deficiency in Children
Intervention: NNC126-0083 (Drug); somatropin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s):
Lene Finnerup Nielsen, Msc, Study Director, Affiliation: Novo Nordisk A/S
Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the
safety, tolerability, pharmacokinetics (the determination of the concentration of the
administered medication in blood over time) and pharmacodynamics (the determination of the
effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083)
in growth hormone deficient children.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Frequency of Adverse events (AEs)
Secondary outcome: AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administrationIGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Brussels 1090, Belgium
Ã…rhus C 8000, Denmark
Toulouse cedex 9 31059, France
Jerusalem 91240, Israel
Skopje 1000, Macedonia, The Former Yugoslav Republic of
Ljubljana 1525, Slovenia
Vitoria 01009, Spain
Cambridge CB2 2QQ, United Kingdom
Additional Information
Clinical Trials at Novo Nordisk
Starting date: August 2009
Last updated: August 2, 2012
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