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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: May 21, 2012
Last updated: July 2, 2015
Last verified: July 2015
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.

Condition Intervention
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Genetic Disorder
Turner Syndrome
Drug: somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change from baseline in height [ Time Frame: Week 0, Month 36, final height is reached ] [ Designated as safety issue: No ]
  • Incidence of adverse reactions (ADRs) [ Time Frame: 36 months, accumulation of study period ] [ Designated as safety issue: No ]

Enrollment: 2016
Study Start Date: May 2005
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Somatropin Drug: somatropin
Collection of safety and efficacy data in connection with use of somatropin (Norditropin®) in daily clinical practice.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from normal practice who have been deemed appropriate to receive somatropin ( Norditropin®) as part of routine out-patient care by the prescribing physician.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01604161

Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01604161     History of Changes
Other Study ID Numbers: GH-3910 
Study First Received: May 21, 2012
Last Updated: July 2, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Turner Syndrome
Adnexal Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Chromosome Disorders
Congenital Abnormalities
Disorders of Sex Development
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Ovarian Diseases
Pathologic Processes
Pituitary Diseases processed this record on May 01, 2016