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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01604161
First received: May 21, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 ]

Estimated Enrollment: 2000
Study Start Date: May 2005
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 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.

  Eligibility

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.

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
  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 ClinicalTrials.gov identifier: NCT01604161

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

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01604161     History of Changes
Other Study ID Numbers: GH-3910
Study First Received: May 21, 2012
Last Updated: July 23, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Genetic Diseases, Inborn
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Gonadal Disorders
Ovarian Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on August 28, 2014