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NCT00936403 Clinical Trial

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

Growth Hormone Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00936403
Other study ID # NN8630-1824
Secondary ID 2008-008240-25
Status Completed
Phase Phase 2
First received July 9, 2009
Last updated February 6, 2017
Start date August 2009
Est. completion date July 2010

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NNC126-0083
One single dose administered in four dose levels in an escalating order
• somatropin
A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant

Locations
Country Name City State
Belgium Novo Nordisk Investigational Site Brussels
Belgium Novo Nordisk Investigational Site Gent
Czech Republic Novo Nordisk Investigational Site Prague 5
Denmark Novo Nordisk Investigational Site Århus C
France Novo Nordisk Investigational Site BRON cedex
France Novo Nordisk Investigational Site Toulouse cedex 9
Israel Novo Nordisk Investigational Site Beer Sheva
Israel Novo Nordisk Investigational Site Jerusalem
Israel Novo Nordisk Investigational Site Kfar Saba
Israel Novo Nordisk Investigational Site Petah Tikva
Macedonia, The Former Yugoslav Republic of Novo Nordisk Investigational Site Skopje
Slovenia Novo Nordisk Investigational Site Ljubljana
Spain Novo Nordisk Investigational Site Barcelona
Spain Novo Nordisk Investigational Site Esplugues Llobregat
Spain Novo Nordisk Investigational Site Santiago de Compostela
Spain Novo Nordisk Investigational Site Vitoria
Turkey Novo Nordisk Investigational Site Ankara
Turkey Novo Nordisk Investigational Site Ankara
Turkey Novo Nordisk Investigational Site Istanbul
United Kingdom Novo Nordisk Investigational Site Birmingham
United Kingdom Novo Nordisk Investigational Site Cambridge

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Denmark,  France,  Israel,  Macedonia, The Former Yugoslav Republic of,  Slovenia,  Spain,  Turkey,  United Kingdom, 

References & Publications (1)

de Schepper J, Rasmussen MH, Gucev Z, Eliakim A, Battelino T. Long-acting pegylated human GH in children with GH deficiency: a single-dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics. Eur J Endocrinol. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of Adverse events (AEs) 0-10 days after dosing
Secondary AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administration Measured 10 days after dosing
Secondary IGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration Measured 10 days after dosing
See also
  Status Clinical Trial Phase
Completed NCT02229851 - Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. Phase 3
Completed NCT01563926 - Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 3
Completed NCT01562834 - Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients Phase 4
Completed NCT01109017 - Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency N/A
Completed NCT01706783 - A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency Phase 1
Completed NCT01245374 - Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents Phase 4
Completed NCT00184730 - Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT01502124 - Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency Phase 3
Completed NCT00519558 - Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT01604161 - Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome N/A
Completed NCT00102817 - Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children Phase 3
Terminated NCT01698944 - Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency Phase 4
Completed NCT03075644 - A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency Phase 3
Recruiting NCT02616562 - Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency Phase 2
Completed NCT02005198 - Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) N/A
Completed NCT00567385 - Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 4
Completed NCT01009905 - An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone) N/A
Completed NCT03186495 - Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function Phase 1
Completed NCT00934063 - An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® N/A
Completed NCT00722540 - Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Phase 1

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