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CompletedNCT01543867GrowthWIN IIUpdated Mar 30, 2015

Safety and Efficacy of Long-term Somatropin Treatment in Children

An observational study in Growth Hormone Disorder, Growth Hormone Deficiency in Children and Foetal Growth Problem, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2015-03-30.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5,442
Ages
Up to 18 Years
Sex
All
01

Study summary

This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.

02

Conditions studied

  • Growth Hormone Disorder
  • Growth Hormone Deficiency in Children
  • Foetal Growth Problem
  • Small for Gestational Age
  • Genetic Disorder
  • Turner Syndrome
  • Growth Disorder
  • Idiopathic Short Stature
03

In context

Dwarfism

125 studies on the registry are indexed under Dwarfism; 19 are open to participants now.

This study's enrollment of 5,442 is above the median of 100 across 44 observational studies indexed under Dwarfism.

Browse Dwarfism studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 101 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

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

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children treated with somatropin

Eligibility criteria

Inclusion Criteria:

  • In need of somatropin or current user
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5,442 participants (actual)

Groups and cohorts

  • Users of somatropin

    Drug: somatropin

Interventions

  • Drugsomatropin

    Prescribed at the discretion of the treating physician according to product labelling

06

What researchers measure

Primary outcomes

  1. Number of adverse events

    Time frame: Up to 10 years

Secondary outcomes

  1. Number of patients continuing somatropin treatment

    Time frame: Up to 10 years

  2. Change in height

    Time frame: Up to 10 years

  3. Onset of puberty in children small for gestational age

    Time frame: Up to 10 years

  4. Co-morbidities in children small for gestational age

    Time frame: Up to 10 years

07

Study locations

1 site
  • Mainz, 55127, Germany
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01543867
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Mar 5, 2012
Start date
Jan 2001
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Mar 30, 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 Mar 2015. You cannot join it, but the record below documents what was studied.

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