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

January 10, 2019 updated by: Novo Nordisk A/S

A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1000005
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Norditropin®
Drug: somatropin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
Time Frame: evaluated binannually for 9 years
evaluated binannually for 9 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of glucose intolerance events during the study period
Time Frame: evaluated biannually for 9 years
evaluated biannually for 9 years
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
Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 26, 2009

Primary Completion (ACTUAL)

November 12, 2018

Study Completion (ACTUAL)

November 12, 2018

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (ESTIMATE)

April 27, 2010

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH-3812
  • U1111-1114-6280 (OTHER: WHO)
  • JapicCTI-101123 (REGISTRY: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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