Observational Prospective Study on Patients Treated With Norditropin®

October 11, 2017 updated by: Novo Nordisk A/S

NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®

This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21249

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

  • Argentina
      • Prov. de Buenos Aires, Argentina, B1636DSU
        • Novo Nordisk Investigational Site
  • Belgium
      • Brussels, Belgium, 1070
        • Novo Nordisk Investigational Site
  • Czechia
      • Prague, Czechia, 16000
        • Novo Nordisk Investigational Site
  • Denmark
      • Copenhagen S, Denmark, 2300
        • Novo Nordisk Investigational Site
  • Finland
      • Espoo, Finland, FI-02600
        • Novo Nordisk Investigational Site
  • France
      • Paris La défense cedex, France, 92932
        • Novo Nordisk Investigational Site
  • Germany
      • Mainz, Germany, 55127
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1025
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin 2, Ireland
        • Novo Nordisk Investigational Site
  • Israel
      • Kfar Saba, Israel, 44425
        • Novo Nordisk Investigational Site
  • Italy
      • Rome, Italy, 00144
        • Novo Nordisk Investigational Site
  • Lithuania
      • Vilnius, Lithuania, 01112
        • Novo Nordisk Investigational Site
  • Luxembourg
      • Luxembourg, Luxembourg
        • Novo Nordisk Investigational Site
  • Netherlands
      • Alphen a/d Rijn, Netherlands
        • Novo Nordisk Investigational Site
  • Norway
      • Rud, Norway, 1309
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 119330
        • Novo Nordisk Investigational Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 3542
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11 070
        • Novo Nordisk Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, SI-1000
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28033
        • Novo Nordisk Investigational Site
  • Sweden
      • Malmö, Sweden, 202 15
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zurich, Switzerland, CH-8050
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Crawley, United Kingdom, RH11 9RT
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice

Description

Inclusion Criteria:

  • Judged by the physician as per the Norditropin® label

Exclusion Criteria:

  • Judged by the physician as per the Norditropin® label

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
A
Adult cohort
Drug: somatropin
The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with adults.
Drug: somatropin
The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with children.
B
Paediatric cohort
Drug: somatropin
The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with adults.
Drug: somatropin
The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of Norditropin® treatment on height gain (change in height) in children
Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Effect of Norditropin® treatment on body weight and body composition in adults
Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children
Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adults
Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.

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

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)

April 1, 2006

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHLIQUID-3676
  • 2008-001674-32 (EudraCT Number)

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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