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CompletedNCT01604161NordiPADUpdated Jul 3, 2015

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

An observational study in Growth Hormone Disorder, Growth Hormone Deficiency in Children and Genetic Disorder, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2015-07-03.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,016
Sex
All
01

Study 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.

02

Conditions studied

  • Growth Hormone Disorder
  • Growth Hormone Deficiency in Children
  • Genetic Disorder
  • Turner Syndrome
03

In context

Genetic Diseases, Inborn

422 studies on the registry are indexed under Genetic Diseases, Inborn; 147 are open to participants now.

This study's enrollment of 2,016 is above the median of 200 across 201 observational studies indexed under Genetic Diseases, Inborn.

Browse Genetic Diseases, Inborn studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Growth hormone deficiency or short stature due to Turner Syndrome where the epiphyseal discs are not closed

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,016 participants (actual)
Patient registry
No

Groups and cohorts

  • Somatropin

    Drug: somatropin

Interventions

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

06

What researchers measure

Primary outcomes

  1. Change from baseline in height

    Time frame: Week 0, Month 36, final height is reached

  2. Incidence of adverse reactions (ADRs)

    Time frame: 36 months, accumulation of study period

07

Study locations

1 site
  • Tokyo, 1000005, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01604161
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
May 23, 2012
Start date
May 2005
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jul 3, 2015

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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