An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

Completed

Conditions studied: Growth Hormone Disorder, Pituitary Dwarfism, Hypopituitarism

In brief

This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.

Key facts

Study ID

NCT01009905

Run by

Novo Nordisk A/S

People needed

22960

Starts

2002-06-24

Expected to finish

2016-09-30

Last updated by the study team

2017-04-12

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained
• Children or adult patients treated with Norditropin® for an appropriate condition as prescribed by their physician

You may not qualify if…

• Patients not being treated with Norditropin®
• Patients who have discontinued treatment with Norditropin®
• Known or suspected allergy to Norditropin® or related products
• Contraindications for somatropin treatment consistent with the Prescribing Information for Norditropin®

Where it is running

• Novo Nordisk Investigational Site — Plainsboro, New Jersey, United States

Full record on ClinicalTrials.gov

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