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

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.

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Key information

Conditions

Growth Hormone Disorder Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genetic Disorder Gonadal Disorders Gonadal Dysgenesis Growth Hormone Deficiency in Children Heart Defects, Congenital Heart Diseases Male Urogenital Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Turner Syndrome Urogenital Abnormalities Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

Collection of safety and efficacy data in connection with use of somatropin (Norditropin®) in daily clinical practice.

Primary outcomes

Change from baseline in height

Time frame: Week 0, Month 36, final height is reached
Incidence of adverse reactions (ADRs)

Time frame: 36 months, accumulation of study period

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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.

Acronym: NordiPAD

Important dates

Study start: 2005
Primary completion: 2015
Study completion: 2015
First posted: May 23, 2012
Registry last updated: Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed