A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00936403
First received: July 9, 2009
Last updated: August 2, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Growth Hormone Disorder Growth Hormone Deficiency in Children |
Drug: NNC126-0083 Drug: somatropin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
combined pituitary hormone deficiency
isolated growth hormone deficiency
metatropic dysplasia
pseudoachondroplasia
Drug Information available for:
Somatropin
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Frequency of Adverse events (AEs) [ Time Frame: 0-10 days after dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | August 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: NNC126-0083 |
Drug: NNC126-0083
One single dose administered in four dose levels in an escalating order
|
| Active Comparator: Norditropin NordiFlex® |
Drug: somatropin
A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant
|
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936403
Locations
| Belgium | |
| Brussels, Belgium, 1090 | |
| Denmark | |
| Århus C, Denmark, 8000 | |
| France | |
| Toulouse cedex 9, France, 31059 | |
| Israel | |
| Jerusalem, Israel, 91240 | |
| Macedonia, The Former Yugoslav Republic of | |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Slovenia | |
| Ljubljana, Slovenia, 1525 | |
| Spain | |
| Vitoria, Spain, 01009 | |
| United Kingdom | |
| Cambridge, United Kingdom, CB2 2QQ | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Lene Finnerup Nielsen, Msc | Novo Nordisk |
More Information
Additional Information:
No publications provided by Novo Nordisk
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00936403 History of Changes |
| Other Study ID Numbers: | NN8630-1824, 2008-008240-25 |
| Study First Received: | July 9, 2009 |
| Last Updated: | August 2, 2012 |
| Health Authority: | Slovenia: Agency of Drugs and Medicinal Products of the Slovenian Republic Belgium: Federal Agency for Medicines and Healthcare Products United Kingdom: Medicines and Healthcare Products Regulatory Agency Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Ministry of Health Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Dwarfism, Pituitary Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013