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CompletedNCT01110928Updated Jan 11, 2019

Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing

An observational study in Foetal Growth Problem and Small for Gestational Age, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2019-01-11.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
227
Sex
All
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Study summary

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).

02

Conditions studied

  • Foetal Growth Problem
  • Small for Gestational Age
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In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,401 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.

Browse Novo Nordisk A/S studies →

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 with SGA short stature that are still growing, who will either receive Norditropin® (somatropin) treatment or completed the GHLIQUID-1517 trial.

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

  • Participation in the GHLIQUID-1517 trial
  • Patients with SGA (small for gestational age) short stature that are still growing

Exclusion criteria

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products
  • Diabetes Mellitus
  • Patients with malignant tumor(s)
  • Pregnant or likely to get pregnant
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
227 participants (actual)
Patient registry
No

Groups and cohorts

  • Norditropin®

    Drug: somatropin

Interventions

  • Drugsomatropin

    Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit.

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What researchers measure

Primary outcomes

  1. Number and type of suspected serious adverse drug reactions (SADRs) during the study period

    Time frame: evaluated binannually for 9 years

Secondary outcomes

  1. Number of glucose intolerance events during the study period

    Time frame: evaluated biannually for 9 years

  2. Adult height

    Time frame: Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician

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Study locations

1 site
  • Novo Nordisk Investigational Site
    Tokyo, 1000005, Japan
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References and documents

Publications

  • Toshiaki Tanaka et al, The effect of growth hormone treatment on age and height at puberty onset in short Japanese children born small for gestational age: interim analysis of Norditropin post-marketing study; Japan, Journal of Japanese Association for Human Auxology; 2017: Vol 23 No. 2 : p59
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2009 to primary completion in Nov 2018, 107 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 19, 2010
First posted
Apr 27, 2010
StartActual
Nov 26, 2009
Primary completionActual
Nov 12, 2018
CompletionActual
Nov 12, 2018
Last update
Jan 11, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01110928
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 27, 2010
Start date
Nov 26, 2009
Primary completion
Nov 12, 2018
Completion
Nov 12, 2018
Last update
Jan 11, 2019

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 Jan 2019. You cannot join it, but the record below documents what was studied.

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