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



Status:Completed
Conditions:Neurology, Endocrine
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:Any - 18
Updated:4/13/2017
Start Date:June 24, 2002
End Date:September 30, 2016

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Trial Summary
Trial Overview
Inclusion Criteria

Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone

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.


Inclusion Criteria:

- Informed consent obtained

- Children or adult patients treated with Norditropin® for an appropriate condition as
prescribed by their physician

Exclusion Criteria:

- 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®
We found this trial at
1
site
Novo Nordisk Investigational Site
Plainsboro, New Jersey 08536
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mi
from
Plainsboro, NJ
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