A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Growth Hormone Deficiency in Children; Growth Hormone Disorder

Treatments: Drug: somatropin; Drug: NNC126-0083

Study type: Interventional

Funder types: Industry

Identifiers

NCT00936403

2008-008240-25 (EudraCT Number)

NN8630-1824

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

NNC126-0083

Experimental group

Treatment:

Drug: NNC126-0083

Norditropin NordiFlex®

Active Comparator group

Treatment:

Drug: somatropin