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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


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 administration

IGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration


Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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