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

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Brief Title

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

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

Brief 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.

Study Phase

Phase 2

Study Type

Interventional

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

Condition

Growth Hormone Disorder

Intervention

NNC126-0083

Study Arms / Comparison Groups

 NNC126-0083
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

31

Start Date

August 2009

Completion Date

July 2010

Primary Completion Date

July 2010

Eligibility 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)

Gender

All

Ages

6 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Global Clinical Registry (GCR, 1452), ,

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT00936403

Organization ID

NN8630-1824

Secondary IDs

2008-008240-25

Responsible Party

Sponsor

Study Sponsor

Novo Nordisk A/S

Study Sponsor

Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

Verification Date

February 2017