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 heightIncidence 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
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