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

NCT01604161 — Completed, 2016 participants, Novo Nordisk A/S
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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.

RegistryNCT01604161, acronym NordiPAD
StatusCompleted
Study typeObservational
Enrollment2016 (Actual)
SponsorNovo Nordisk A/S (Industry)
ConditionsGrowth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome
Interventionssomatropin (Drug)
Datesstart 2005-05-01, primary completion 2015-06-01, completion 2015-06-01, first posted 2012-05-23, last updated 2015-07-03
Locations1 site in Japan

Related Papers Related Patents Related Grants Related Experts
All trials for Growth Hormone Disorder All trials for Growth Hormone Deficiency in Children All trials of somatropin

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
SomatropinDrug: somatropin
  • somatropin (Drug): Collection of safety and efficacy data in connection with use of somatropin (Norditropin®) in daily clinical practice.

+Outcome measures

Primary outcomes

  • Change from baseline in height [Week 0, Month 36, final height is reached]
  • Incidence of adverse reactions (ADRs) [36 months, accumulation of study period]

+Eligibility

Sex: All

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 (1)

FacilityCityCountryStatus
TokyoJapan

+Investigators

  • Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S