A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency (GHD)
Intervention: NNC126-0083 (Drug); NNC126-0083 (Drug); NNC126-0083 (Drug); NNC126-0083 (Drug); somatropin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Lene Finnerup Nielsen, Msc, Study Director, Affiliation: Novo Nordisk
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
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 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: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
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
- GH replacement treatment for at least three months
Exclusion Criteria:
- Evidence of tumour growth or malignant disease
- GHD children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Brussels 1090, Belgium; Recruiting
Ljubljana 1525, Slovenia; Recruiting
Cambridge CB2 2QQ, United Kingdom; Recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: August 2009
Ending date: December 2009
Last updated: August 14, 2009
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