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Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Genetic Disorder; Turner Syndrome

Intervention: somatropin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

Summary

This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin« (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature with Turner Syndrome where epiphysial discs are not closed.

Clinical Details

Official title: A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin« Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs.

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Change from baseline in height

Incidence of adverse reactions (ADRs)

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Growth hormone deficiency or short stature due to Turner Syndrome where the

epiphyseal discs are not closed Exclusion Criteria:

- Diabetic

- Patients with malignant tumors

- Women who are either pregnant or likely to be pregnant

- Known or suspected allergy to study product(s) or related products

Locations and Contacts

Tokyo 1000005, Japan
Additional Information

Clinical Trials at Novo Nordisk

Starting date: May 2005
Last updated: July 2, 2015

Page last updated: August 23, 2015

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